Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-29 @ 5:02 AM
Study NCT ID:
NCT02359357
Status:
COMPLETED
Last Update Posted:
2016-04-08
First Post:
2015-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FTIH - Single and Repeat Oral Doses of FDL169 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-07', 'studyFirstSubmitDate': '2015-01-13', 'studyFirstSubmitQcDate': '2015-02-04', 'lastUpdatePostDateStruct': {'date': '2016-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1A: safety and tolerability for 48 h following single oral doses of FDL169 (Vital signs, electrocardiogram (ECG), safety laboratory data and adverse events (AEs)', 'timeFrame': 'Multiple points from screening to follow-up (up to 28 days)', 'description': 'Vital signs, electrocardiogram (ECG), safety laboratory data and adverse events (AEs)'}, {'measure': 'Part 1B: food effect on the tolerability of FDL169 for 48 h following a single dose', 'timeFrame': 'Multiple points from screening to follow-up (up to 42 days)', 'description': 'Vital signs, ECG, safety laboratory data and AEs'}, {'measure': 'Part 2: safety and tolerability following multiple oral doses of FDL169 (assessed throughout dosing and for 24 h post-final dose) (Vital signs, ECG, safety laboratory data and AEs)', 'timeFrame': 'Multiple points from screening to follow-up (up to 42 days)', 'description': 'Vital signs, ECG, safety laboratory data and AEs'}, {'measure': 'Part 1B: food effect on the pharmacokinetics of FDL169 for 48 h following a single dose', 'timeFrame': 'Multiple points from pre-dose to 48 h post-dose', 'description': 'Pharmacokinetic parameters: Cmax, tmax, lambdaz, t1/2, AUC(0-t), AUC(0-tau), AUC (0-inf) CL/F and AUC%extrapolated'}], 'secondaryOutcomes': [{'measure': 'Part 1: pharmacokinetic profile for 48 h following single oral doses of FDL169', 'timeFrame': 'Multiple points from pre-dose to 48 h post-dose', 'description': 'Pharmacokinetic parameters: Cmax, tmax, lambdaz, t1/2, AUC(0-t), AUC(0-tau), AUC (0-inf) CL/F and AUC%extrapolated'}, {'measure': 'Part 2: pharmacokinetic profile following multiple oral doses of FDL169 (assessed throughout dosing and for 24 h post-final dose)', 'timeFrame': 'Multiple points from pre-dose to 24 h post-dosing on Day 14', 'description': 'Pharmacokinetic parameters: Cmax, tmax, lambdaz, t1/2, AUC(0-t), AUC(0-tau), AUC (0-inf) CL/F and AUC%extrapolated'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'To determine the safety and tolerability of single and multiple escalating doses of FDL169 in healthy male subjects.', 'detailedDescription': 'This study is the first time in human study and consists of two parts.\n\nPart 1A:\n\nPart 1 of the study is a randomised, double-blind, placebo-controlled, dose-escalation, first-time-in-human study to assess the safety, tolerability and PK profiles following single oral administrations of FDL169 to healthy male volunteers. Sixty-four (64) male subjects (8 per cohort) will be included in Part 1 of the study. Up to eight dose levels of FDL169 are planned to be tested in Part 1 of the study.\n\nPart 1B:\n\nOpen label. Following completion of Part 1A of the study, an additional cohort of 8 subjects will receive a single dose of FDL169 in both fasted and fed states\n\nPart 2:\n\nPart 2 of the study is a randomised, double-blind, placebo-controlled, dose-escalation study to assess the safety, tolerability and PK profiles following multiple oral administrations of FDL169 to healthy male subjects. Forty-eight male subjects, in cohorts of twelve, will be included in Part 2 of the study. It is planned to test up to four dose levels of FDL169 in Part 2.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy male subjects aged 18 to 45 years who fulfil standard safety screening assessments for the study (haematology/biochemistry, urinalysis, 12-lead electrocardiogram (ECG), vital signs and oral temperature) and who in the opinion of the Investigator, are medically suitable to participate in the study. Male subjects and their partners must be willing to use an effective method of contraception from first dose of investigational medicinal product (IMP) and for 3 months after the last dose of IMP.\n\nExclusion Criteria:\n\n1. Participation in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months.\n2. Subjects who have history or presence of clinically significant cardiovascular, pulmonary, renal, hepatic, haematologic, gastrointestinal (endocrine or immunologic disease), at Screening.\n3. Donation of 500 mL or more blood within the previous 3 months.\n4. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 21 days (or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and Flatley Discovery Labs Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.\n5. Smoking or use tobacco products or substitutes equivalent to \\> 15 cigarettes/day.\n6. Any subject attempting to father a child within 3 months of their Follow-Up Visit.'}, 'identificationModule': {'nctId': 'NCT02359357', 'briefTitle': 'FTIH - Single and Repeat Oral Doses of FDL169 in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Flatley Discovery Lab LLC'}, 'officialTitle': 'A Phase 1, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation First-Time-in-Human Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of Single and Repeat Oral Doses of FDL169 in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'FDL169-2014-01'}, 'secondaryIdInfos': [{'id': 'RD 674/25728', 'type': 'OTHER', 'domain': 'Sponsor'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo single dose', 'description': 'Placebo administered as a single dose', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Single dose (Dose level 1)', 'description': 'FDL169 (Dose level 1) administered as a single dose', 'interventionNames': ['Drug: FDL169']}, {'type': 'EXPERIMENTAL', 'label': 'Single dose (Dose level 2)', 'description': 'FDL169 (Dose level 2) administered as a single dose', 'interventionNames': ['Drug: FDL169']}, {'type': 'EXPERIMENTAL', 'label': 'Single dose (Dose level 3)', 'description': 'FDL169 (Dose level 3) administered as a single dose', 'interventionNames': ['Drug: FDL169']}, {'type': 'EXPERIMENTAL', 'label': 'Single dose (Dose level 4)', 'description': 'FDL169 (Dose level 4) administered as a single dose', 'interventionNames': ['Drug: FDL169']}, {'type': 'EXPERIMENTAL', 'label': 'Single dose (Dose level 5)', 'description': 'FDL169 (Dose level 5) administered as a single dose', 'interventionNames': ['Drug: FDL169']}, {'type': 'EXPERIMENTAL', 'label': 'Single dose (Dose level 6)', 'description': 'FDL169 (Dose level 6) administered as a single dose', 'interventionNames': ['Drug: FDL169']}, {'type': 'EXPERIMENTAL', 'label': 'Single dose (Dose level 7)', 'description': 'FDL169 (Dose level 7) administered as a single dose', 'interventionNames': ['Drug: FDL169']}, {'type': 'EXPERIMENTAL', 'label': 'Single dose (Dose level 8)', 'description': 'FDL169 (Dose level 8) administered as a single dose', 'interventionNames': ['Drug: FDL169']}, {'type': 'EXPERIMENTAL', 'label': 'Additional single dose 1', 'description': 'Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8)', 'interventionNames': ['Drug: FDL169']}, {'type': 'EXPERIMENTAL', 'label': 'Additional single dose 2', 'description': 'Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8)', 'interventionNames': ['Drug: FDL169']}, {'type': 'EXPERIMENTAL', 'label': 'Additional single dose 3', 'description': 'Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8)', 'interventionNames': ['Drug: FDL169']}, {'type': 'EXPERIMENTAL', 'label': 'Additional single dose 4', 'description': 'Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8)', 'interventionNames': ['Drug: FDL169']}, {'type': 'EXPERIMENTAL', 'label': 'Food effect - fasted', 'description': 'Single dose of FDL169 in fasted conditions', 'interventionNames': ['Drug: FDL169']}, {'type': 'EXPERIMENTAL', 'label': 'Food effect - fed', 'description': 'Single dose of FDL169 in fed conditions', 'interventionNames': ['Drug: FDL169']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo - multiple dose', 'description': 'Repeat doses of placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple dose - Dose level 1', 'description': 'Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8)', 'interventionNames': ['Drug: FDL169']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple dose - Dose level 2', 'description': 'Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8)', 'interventionNames': ['Drug: FDL169']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple dose - Dose level 3', 'description': 'Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8)', 'interventionNames': ['Drug: FDL169']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple dose - Dose level 4', 'description': 'Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8)', 'interventionNames': ['Drug: FDL169']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple dose - additional dose level 1', 'description': 'Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8)', 'interventionNames': ['Drug: FDL169']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple dose - additional dose level 2', 'description': 'Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8)', 'interventionNames': ['Drug: FDL169']}], 'interventions': [{'name': 'FDL169', 'type': 'DRUG', 'armGroupLabels': ['Additional single dose 1', 'Additional single dose 2', 'Additional single dose 3', 'Additional single dose 4', 'Food effect - fasted', 'Food effect - fed', 'Multiple dose - Dose level 1', 'Multiple dose - Dose level 2', 'Multiple dose - Dose level 3', 'Multiple dose - Dose level 4', 'Multiple dose - additional dose level 1', 'Multiple dose - additional dose level 2', 'Single dose (Dose level 1)', 'Single dose (Dose level 2)', 'Single dose (Dose level 3)', 'Single dose (Dose level 4)', 'Single dose (Dose level 5)', 'Single dose (Dose level 6)', 'Single dose (Dose level 7)', 'Single dose (Dose level 8)']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo - multiple dose', 'Placebo single dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CF48 4DR', 'city': 'Merthyr Tydfil', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Simbec Research Ltd', 'geoPoint': {'lat': 51.74794, 'lon': -3.37779}}], 'overallOfficials': [{'name': 'Salvatore Febbraro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Simbec Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Flatley Discovery Lab LLC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}