Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-29 @ 8:04 AM
Study NCT ID:
NCT02080468
Status:
COMPLETED
Last Update Posted:
2019-03-11
First Post:
2014-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluate the Effect of Ethinyl Estradiol/Norgestimate on the Pharmacokinetics of Lomitapide in Healthy Female Subjects
Sponsor:
Organization:
Raw JSON
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0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PK of Lomitapide (Lomitapide Alone)', 'description': 'PK of lomitapide following administration of lomitapide alone'}, {'id': 'OG001', 'title': 'PK of Lomitapide (Coadministered Simultaneously)', 'description': 'PK of lomitapide following administration of lomitapide coadministered with EE/Norgestimate simultaneously'}, {'id': 'OG002', 'title': 'PK of M1 (Lomitapide Alone)', 'description': 'PK of M1 following administration of lomitapide alone'}, {'id': 'OG003', 'title': 'PK of M1 (Coadministered Simultaneously)', 'description': 'PK of M1 following administration of lomitapide coadministered with EE/Norgestimate simultaneously'}, {'id': 'OG004', 'title': 'PK of M3 (Lomitapide Alone)', 'description': 'PK of M3 following administration of lomitapide 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population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.'}, {'type': 'PRIMARY', 'title': 'Tmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PK of Lomitapide (Lomitapide Alone)', 'description': 'PK of lomitapide following administration of lomitapide alone'}, {'id': 'OG001', 'title': 'PK of Lomitapide (Coadministered Simultaneously)', 'description': 'PK of lomitapide following administration of lomitapide coadministered with EE/Norgestimate simultaneously'}, {'id': 'OG002', 'title': 'PK of M1 (Lomitapide Alone)', 'description': 'PK of M1 following administration of lomitapide alone'}, {'id': 'OG003', 'title': 'PK of M1 (Coadministered Simultaneously)', 'description': 'PK of M1 following administration of lomitapide coadministered with EE/Norgestimate simultaneously'}, {'id': 'OG004', 'title': 'PK of M3 (Lomitapide Alone)', 'description': 'PK of M3 following administration of lomitapide alone'}, {'id': 'OG005', 'title': 'PK of M3 (Coadministered Simultaneously)', 'description': 'PK of M3 following administration of lomitapide coadministered with EE/Norgestimate simultaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '6.00', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '12.0'}, {'value': '5.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '18.0'}, {'value': '8.28', 'groupId': 'OG002', 'lowerLimit': '5.00', 'upperLimit': '12.0'}, {'value': '6.00', 'groupId': 'OG003', 'lowerLimit': '2.00', 'upperLimit': '12.0'}, {'value': '5.02', 'groupId': 'OG004', 'lowerLimit': '3.00', 'upperLimit': '12.0'}, {'value': '3.97', 'groupId': 'OG005', 'lowerLimit': '1.00', 'upperLimit': '6.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing', 'description': 'Time to reach maximum observed plasma concentration of lomitapide and its 2 primary metabolites, M1 \\& M3.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic Analysis population included all subjects. 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Only subjects who completed both periods were included in the ANOVA analyses.'}, {'type': 'PRIMARY', 'title': 't1/2 for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PK of Lomitapide (Lomitapide Alone)', 'description': 'PK of lomitapide following administration of lomitapide alone'}, {'id': 'OG001', 'title': 'PK of Lomitapide (Coadministered Simultaneously)', 'description': 'PK of lomitapide following administration of lomitapide coadministered with EE/Norgestimate simultaneously'}, {'id': 'OG002', 'title': 'PK of M1 (Lomitapide Alone)', 'description': 'PK of M1 following administration of lomitapide alone'}, {'id': 'OG003', 'title': 'PK of M1 (Coadministered Simultaneously)', 'description': 'PK of M1 following administration of lomitapide coadministered with EE/Norgestimate simultaneously'}, {'id': 'OG004', 'title': 'PK of M3 (Lomitapide Alone)', 'description': 'PK of M3 following administration of lomitapide alone'}, {'id': 'OG005', 'title': 'PK of M3 (Coadministered Simultaneously)', 'description': 'PK of M3 following administration of lomitapide coadministered with EE/Norgestimate simultaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '51.0', 'spread': '16.1', 'groupId': 'OG000'}, {'value': '53.6', 'spread': '19.0', 'groupId': 'OG001'}, {'value': '32.5', 'spread': '20.3', 'groupId': 'OG002'}, {'value': '36.8', 'spread': '30.3', 'groupId': 'OG003'}, {'value': '38.3', 'spread': '32.7', 'groupId': 'OG004'}, {'value': '39.8', 'spread': '26.2', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing', 'description': 'Apparent terminal elimination half-life of lomitapide and its 2 primary metabolites, M1 \\& M3.', 'unitOfMeasure': 'hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic Analysis population included all subjects. 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Only subjects who completed both periods were included in the ANOVA analyses.'}, {'type': 'SECONDARY', 'title': 'Tmax for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PK of Lomitapide (Lomitapide Alone)', 'description': 'PK of lomitapide following administration of lomitapide alone'}, {'id': 'OG001', 'title': 'PK of Lomitapide (Codministered 12 Hours Apart)', 'description': 'PK of lomitapide following administration of lomitapide coadministered with EE/Norgestimate 12 hours apart'}, {'id': 'OG002', 'title': 'PK of M1 (Lomitapide Alone)', 'description': 'PK of M1 following administration of lomitapide alone'}, {'id': 'OG003', 'title': 'PK of M1 (Coadministered 12 Hours Apart)', 'description': 'PK of M1 following administration of lomitapide coadministered with EE/Norgestimate 12 hours apart'}, {'id': 'OG004', 'title': 'PK of M3 (Lomitapide Alone)', 'description': 'PK of M3 following administration of lomitapide alone'}, {'id': 'OG005', 'title': 'PK of M3 (Coadministered 12 Hours Apart)', 'description': 'PK of M3 following administration of lomitapide coadministered with EE/Norgestimate 12 hours apart'}], 'classes': [{'categories': [{'measurements': [{'value': '8.00', 'groupId': 'OG000', 'lowerLimit': '5.00', 'upperLimit': '10.0'}, {'value': '8.00', 'groupId': 'OG001', 'lowerLimit': '3.00', 'upperLimit': '11.8'}, {'value': '9.07', 'groupId': 'OG002', 'lowerLimit': '5.00', 'upperLimit': '12.0'}, {'value': '8.00', 'groupId': 'OG003', 'lowerLimit': '3.00', 'upperLimit': '11.9'}, {'value': '6.00', 'groupId': 'OG004', 'lowerLimit': '5.00', 'upperLimit': '10.0'}, {'value': '5.50', 'groupId': 'OG005', 'lowerLimit': '2.00', 'upperLimit': '8.40'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing', 'description': 'Time to reach maximum observed plasma concentration of lomitapide and its metabolites, M1 \\& M3.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.'}, {'type': 'SECONDARY', 'title': 'AUC0-t for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PK of Lomitapide (Lomitapide Alone)', 'description': 'PK of lomitapide following administration of lomitapide alone'}, {'id': 'OG001', 'title': 'PK of Lomitapide (Codministered 12 Hours Apart)', 'description': 'PK of lomitapide following administration of lomitapide coadministered with EE/Norgestimate 12 hours apart'}, {'id': 'OG002', 'title': 'PK of M1 (Lomitapide Alone)', 'description': 'PK of M1 following administration of lomitapide alone'}, {'id': 'OG003', 'title': 'PK of M1 (Coadministered 12 Hours Apart)', 'description': 'PK of M1 following administration of lomitapide coadministered with EE/Norgestimate 12 hours apart'}, {'id': 'OG004', 'title': 'PK of M3 (Lomitapide Alone)', 'description': 'PK of M3 following administration of lomitapide alone'}, {'id': 'OG005', 'title': 'PK of M3 (Coadministered 12 Hours Apart)', 'description': 'PK of M3 following administration of lomitapide coadministered with EE/Norgestimate 12 hours apart'}], 'classes': [{'categories': [{'measurements': [{'value': '37.6', 'spread': '49.9', 'groupId': 'OG000'}, {'value': '46.5', 'spread': '55.1', 'groupId': 'OG001'}, {'value': '92.3', 'spread': '31.1', 'groupId': 'OG002'}, {'value': '93.7', 'spread': '34.2', 'groupId': 'OG003'}, {'value': '520', 'spread': '30.1', 'groupId': 'OG004'}, {'value': '377', 'spread': '31.9', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing', 'description': 'Area under the concentration-time curve from zero to last quantifiable concentration of lomitapide and its metabolites, M1 \\& M3.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.'}, {'type': 'SECONDARY', 'title': 'AUC0-∞ for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PK of Lomitapide (Lomitapide Alone)', 'description': 'PK of lomitapide following administration of lomitapide alone'}, {'id': 'OG001', 'title': 'PK of Lomitapide (Codministered 12 Hours Apart)', 'description': 'PK of lomitapide following administration of lomitapide coadministered with EE/Norgestimate 12 hours apart'}, {'id': 'OG002', 'title': 'PK of M1 (Lomitapide Alone)', 'description': 'PK of M1 following administration of lomitapide alone'}, {'id': 'OG003', 'title': 'PK of M1 (Coadministered 12 Hours Apart)', 'description': 'PK of M1 following administration of lomitapide coadministered with EE/Norgestimate 12 hours apart'}, {'id': 'OG004', 'title': 'PK of M3 (Lomitapide Alone)', 'description': 'PK of M3 following administration of lomitapide alone'}, {'id': 'OG005', 'title': 'PK of M3 (Coadministered 12 Hours Apart)', 'description': 'PK of M3 following administration of lomitapide coadministered with EE/Norgestimate 12 hours apart'}], 'classes': [{'categories': [{'measurements': [{'value': '41.1', 'spread': '50.9', 'groupId': 'OG000'}, {'value': '51.2', 'spread': '55.3', 'groupId': 'OG001'}, {'value': '94.5', 'spread': '31.3', 'groupId': 'OG002'}, {'value': '96.4', 'spread': '34.6', 'groupId': 'OG003'}, {'value': '528', 'spread': '30.0', 'groupId': 'OG004'}, {'value': '383', 'spread': '31.7', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing', 'description': 'Area under the concentration-time curve from zero to infinity of lomitapide and its metabolites, M1 \\& M3.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.'}, {'type': 'SECONDARY', 'title': 't1/2 for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PK of Lomitapide (Lomitapide Alone)', 'description': 'PK of lomitapide following administration of lomitapide alone'}, {'id': 'OG001', 'title': 'PK of Lomitapide (Codministered 12 Hours Apart)', 'description': 'PK of lomitapide following administration of lomitapide coadministered with EE/Norgestimate 12 hours apart'}, {'id': 'OG002', 'title': 'PK of M1 (Lomitapide Alone)', 'description': 'PK of M1 following administration of lomitapide alone'}, {'id': 'OG003', 'title': 'PK of M1 (Coadministered 12 Hours Apart)', 'description': 'PK of M1 following administration of lomitapide coadministered with EE/Norgestimate 12 hours apart'}, {'id': 'OG004', 'title': 'PK of M3 (Lomitapide Alone)', 'description': 'PK of M3 following administration of lomitapide alone'}, {'id': 'OG005', 'title': 'PK of M3 (Coadministered 12 Hours Apart)', 'description': 'PK of M3 following administration of lomitapide coadministered with EE/Norgestimate 12 hours apart'}], 'classes': [{'categories': [{'measurements': [{'value': '51.0', 'spread': '22.2', 'groupId': 'OG000'}, {'value': '52.0', 'spread': '16.1', 'groupId': 'OG001'}, {'value': '36.2', 'spread': '21.0', 'groupId': 'OG002'}, {'value': '37.2', 'spread': '19.1', 'groupId': 'OG003'}, {'value': '38.0', 'spread': '28.0', 'groupId': 'OG004'}, {'value': '33.6', 'spread': '23.2', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing', 'description': 'Apparent terminal elimination half-life of lomitapide and its metabolites, M1 \\& M3.', 'unitOfMeasure': 'hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lomitapide & EE/Norgestimate - Taken Together', 'description': '2 single oral doses of lomitapide (20 mg) (Day 1 \\& Day 22)\n\n21 single oral doses of EE/Norgestimate(Day 8 through day 28)\n\nlomitapide: 20 mg\n\nEE/norgestimate: 1x0.035-mg EE/0.25-mg norgestimate tablet'}, {'id': 'FG001', 'title': 'Lomitapide & EE/Norgestimate - Taken 12 Hours Apart', 'description': '2 single oral doses of lomitapide (20 mg) (Day 1 \\& Day 22)\n\n21 single oral doses of EE/Norgestimate(Day 9 through day 29)\n\nlomitapide: 20 mg\n\nEE/norgestimate: 1x0.035-mg EE/0.25-mg norgestimate tablet'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lomitapide & EE/Norgestimate - Taken Together', 'description': '2 single oral doses of lomitapide (20 mg) (Day 1 \\& Day 22)\n\n21 single oral doses of EE/Norgestimate(Day 8 through day 28)\n\nlomitapide: 20 mg\n\nEE/norgestimate: 1x0.035-mg EE/0.25-mg norgestimate tablet'}, {'id': 'BG001', 'title': 'Lomitapide & EE/Norgestimate - Taken 12 Hours Apart', 'description': '2 single oral doses of lomitapide (20 mg) (Day 1 \\& Day 22)\n\n21 single oral doses of EE/Norgestimate(Day 9 through day 29)\n\nlomitapide: 20 mg\n\nEE/norgestimate: 1x0.035-mg EE/0.25-mg norgestimate tablet'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30', 'spread': '6.4', 'groupId': 'BG000'}, {'value': '29', 'spread': '5.7', 'groupId': 'BG001'}, {'value': '29', 'spread': '6.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2014-04-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-16', 'studyFirstSubmitDate': '2014-03-05', 'resultsFirstSubmitDate': '2015-06-23', 'studyFirstSubmitQcDate': '2014-03-05', 'lastUpdatePostDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-16', 'studyFirstPostDateStruct': {'date': '2014-03-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-04-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)', 'timeFrame': '1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing', 'description': 'Maximum observed plasma concentration of lomitapide and its 2 primary metabolites, M1 \\& M3'}, {'measure': 'Tmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)', 'timeFrame': '1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing', 'description': 'Time to reach maximum observed plasma concentration of lomitapide and its 2 primary metabolites, M1 \\& M3.'}, {'measure': 'AUC0-t for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)', 'timeFrame': '1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing', 'description': 'Area under the concentration-time curve from zero to last quantifiable concentration of lomitapide and its 2 primary metabolites, M1 \\& M3.'}, {'measure': 'AUC0-∞ for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)', 'timeFrame': '1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing', 'description': 'Area under the concentration-time curve from zero to infinity of lomitapide and its 2 primary metabolites, M1 \\& M3.'}, {'measure': 't1/2 for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)', 'timeFrame': '1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing', 'description': 'Apparent terminal elimination half-life of lomitapide and its 2 primary metabolites, M1 \\& M3.'}], 'secondaryOutcomes': [{'measure': 'Cmax for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)', 'timeFrame': '1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing', 'description': 'Maximum observed plasma concentration of lomitapide and its metabolites, M1 \\& M3.'}, {'measure': 'Tmax for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)', 'timeFrame': '1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing', 'description': 'Time to reach maximum observed plasma concentration of lomitapide and its metabolites, M1 \\& M3.'}, {'measure': 'AUC0-t for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)', 'timeFrame': '1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing', 'description': 'Area under the concentration-time curve from zero to last quantifiable concentration of lomitapide and its metabolites, M1 \\& M3.'}, {'measure': 'AUC0-∞ for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)', 'timeFrame': '1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing', 'description': 'Area under the concentration-time curve from zero to infinity of lomitapide and its metabolites, M1 \\& M3.'}, {'measure': 't1/2 for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)', 'timeFrame': '1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing', 'description': 'Apparent terminal elimination half-life of lomitapide and its metabolites, M1 \\& M3.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Effect', 'Ethinyl Estradiol/Norgestimate', 'Pharmacokinetics', 'Lomitapide.'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to assess the effect of ethinyl estradiol (EE)/norgestimate, a weak cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetics (PK) of lomitapide and 2 primary metabolites, M1 and M3.', 'detailedDescription': 'This study will be a single center, randomized, open-label, 2 arm study to evaluate the effects of EE/norgestimate, a weak CYP3A4 inhibitor, on the PK of lomitapide in healthy female subjects when EE/norgestimate is administered simultaneously with lomitapide and when administration is separated by 12 hours.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy females, between 18 and 40 years of age inclusive\n2. BMI between 18.5 and 30.0 kg/m2, inclusive; total body weight of \\>110 lbs (50 kg);\n3. in good health, determined by no clinically significant or relevant abnormalities identified by a detailed medical history and physical exam\n4. no known history of hypersensitivity or previous intolerance to lomitapide or EE/norgestimate\n5. creatine phosphokinase, AST, and ALT levels must be below 1.5 times the upper limit of normal\n6. clinical laboratory evaluations within the reference range for the test laboratory\n7. negative test for selected drugs of abuse\n8. negative hepatitis panel and negative HIV antibody screens\n9. are of childbearing potential(ie, not postmenopausal or surgically sterile). All subjects must have a negative serum beta pregnancy test.\n10. able to comprehend and willing to sign an Informed Consent Form\n\nExclusion Criteria:\n\n1. significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, or psychiatric disorder\n2. history of unexplained breast abnormalities or abnormal uterine bleeding\n3. history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance\n4. history of stomach or intestinal surgery or resection\n5. history of Gilbert's Syndrome or suspicion of Gilbert's Syndrome\n6. subjects who have an abnormality in the 12-lead ECG\n7. use of any drugs of abuse for 6 months prior to Check-in;\n8. subjects who consume more than 14 units of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse within 1 year prior to Check-in\n9. use of any tobacco- or nicotine-containing products within 6 months prior to Check-in;\n10. participation in any other investigational study drug trial within 30 days prior to Check-in;\n11. use of any prescription medications/products within 14 days prior to Check-in unless deemed acceptable by the Investigator and Sponsor\n12. use of any over-the-counter, nonprescription preparations within 7 days prior to Check-in, unless deemed acceptable by the Investigator and Sponsor\n13. use of alcohol-, grapefruit- (including star fruit), or caffeine-containing foods or beverages within 72 hours prior to Check-in and through Study Completion\n14. use of oral (except scheduled administration of EE/norgestimate), implantable, injectable, or transdermal contraceptives\n15. use of hormone replacement therapy\n16. poor peripheral venous access;\n17. donation of blood (500 mL) from 30 days prior to Screening through Study Completion\n18. receipt of blood products within 2 months prior to Check-in;\n19. any acute or chronic condition, scheduled hospitalization (inclusive of elective surgery during study) or scheduled travel prior to completion of all study procedures which, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study;\n20. subjects who, in the opinion of the Investigator, should not participate in this study."}, 'identificationModule': {'nctId': 'NCT02080468', 'briefTitle': 'Evaluate the Effect of Ethinyl Estradiol/Norgestimate on the Pharmacokinetics of Lomitapide in Healthy Female Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aegerion Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 1, Open-Label, Randomized, 2-Arm Study to Evaluate the Effect of Ethinyl Estradiol/Norgestimate (Ortho Cyclen®), a Weak CYP3A4 Inhibitor, on the Pharmacokinetics of Lomitapide in Healthy Female Subjects', 'orgStudyIdInfo': {'id': 'AEGR-733-029'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: Lomitapide & EE/Norgestimate - Taken Together', 'description': 'Lomitapide \\& EE/Norgestimate - Taken Together 2 single oral doses of lomitapide (20 mg) (Day 1 \\& Day 22) 21 single oral doses of EE/Norgestimate(Day 8 through day 28)', 'interventionNames': ['Drug: lomitapide', 'Drug: EE/norgestimate']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: Lomitapide & EE/Norgestimate - Taken 12 Hours Apart', 'description': 'Lomitapide \\& EE/Norgestimate - Taken 12 hours apart 2 single oral doses of lomitapide (20 mg) (Day 1 \\& Day 22) 21 single oral doses of EE/Norgestimate(Day 9 through day 29)', 'interventionNames': ['Drug: lomitapide', 'Drug: EE/norgestimate']}], 'interventions': [{'name': 'lomitapide', 'type': 'DRUG', 'otherNames': ['Juxtapid'], 'description': '20 mg', 'armGroupLabels': ['Arm 1: Lomitapide & EE/Norgestimate - Taken Together', 'Arm 2: Lomitapide & EE/Norgestimate - Taken 12 Hours Apart']}, {'name': 'EE/norgestimate', 'type': 'DRUG', 'otherNames': ['Ortho Cylclen'], 'description': '1x0.035-mg EE/0.25-mg norgestimate tablet', 'armGroupLabels': ['Arm 1: Lomitapide & EE/Norgestimate - Taken Together', 'Arm 2: Lomitapide & EE/Norgestimate - Taken 12 Hours Apart']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Covance Clinical Research Unit, Inc', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Mark Sumeray, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cheif Medical Officer'}, {'name': 'T. Alex King, MD, CPI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Covance'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aegerion Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}