Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-01-10 @ 4:39 PM
Study NCT ID:
NCT02157558
Status:
COMPLETED
Last Update Posted:
2014-09-08
First Post:
2014-06-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-Label Drug-Drug Interaction Study of Telotristat Etiprate and Fexofenadine in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C093230', 'term': 'fexofenadine'}, {'id': 'C000592493', 'term': 'telotristat'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'lastUpdateSubmitDate': '2014-09-05', 'studyFirstSubmitDate': '2014-06-04', 'studyFirstSubmitQcDate': '2014-06-05', 'lastUpdatePostDateStruct': {'date': '2014-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fexofenadine plasma concentration in combination with steady state telotristat etiprate', 'timeFrame': 'Day 10'}], 'secondaryOutcomes': [{'measure': 'Number of treatment emergent adverse events', 'timeFrame': '14 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Drug Interactions']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of steady-state telotristat ethyl on the pharmacokinetics (PK) of single-dose fexofenadine in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult subjects aged ≥18 to ≤55 years of age at screening\n* Body mass index ≥18.0 to ≤32.0 kg/m\\^2\n* Acceptable vital signs at Screening: Systolic blood pressure = 90-140 mm Hg, Diastolic blood pressure = 50-90 mm Hg, Heart rate = 40-100 beats per minute\n* Willingness to adhere to the restrictions outlined in the protocol\n* Able to comprehend and sign the Informed Consent Form\n\nExclusion Criteria:\n\n* Presence of any clinically significant physical, laboratory, or ECG finding that may interfere with the study in the opinion of the Investigator\n* Use of any medications, herbal tea, energy drink, herbal products, or supplements within 14 days of Day 1\n* Receipt of any investigational agent or study drug within 30 days or 5 half-lives prior to Screening\n* Receipt of any protein- or antibody-based therapeutic agent within 3 months of Screening\n* Prior exposure to telotristat etiprate\n* Use of tobacco, smoking cessation products, or nicotine products within 3 months prior to Screening\n* History of major surgery within 6 months prior to Screening\n* History of any GI surgery that may induce malabsorption\n* History of any serious adverse reaction or hypersensitivity to any component of fexofenadine\n* History of renal disease, or significantly abnormal glomerular filtration rate (\\<90 mL/min as calculated using the Cockcroft-Gault equation) at Screening\n* History of hepatic disease, or significantly abnormal liver function tests at Screening\n* History of any clinically significant psychiatric, renal, hepatic, pancreatic, cardiovascular, neurological, endocrinologic, hematological, or GI abnormality\n* History of any active infection within 14 days prior to first dosing\n* History of alcohol or substance abuse within 2 years prior to Screening\n* Positive hepatitis panel (including hepatitis B surface antigen and hepatitis C virus antibody) or positive human immunodeficiency virus antibody screens\n* Concurrent conditions that could interfere with safety and/or tolerability measurements\n* Donation or loss of \\>500 mL of blood or blood product within 3 months prior to Screening\n* Women who are breastfeeding or are planning to become pregnant during the study\n* Positive serum pregnancy test (females only)\n* Positive urine screen for selected drugs of abuse and cotinine\n* Consumption of alcohol within 48 hours prior to study start\n* Consumption of caffeine- and/or xanthine-containing products within 72 hours of study start\n* Consumption of grapefruit, Seville oranges, and grapefruit- or Seville orange-containing products within 72 hours prior to study start\n* Unable or unwilling to communicate or cooperate with the Investigator for any reason\n* Use of any drugs or substances that are known to be substrates, inducers, or inhibitors of CYP3A4 within 30 days prior to the first dose'}, 'identificationModule': {'nctId': 'NCT02157558', 'briefTitle': 'An Open-Label Drug-Drug Interaction Study of Telotristat Etiprate and Fexofenadine in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lexicon Pharmaceuticals'}, 'officialTitle': 'A Phase 1, Open-label, Single-center, 2-period, Single Sequence Drug-drug Interaction Study to Evaluate the Effects of Multiple-dose Telotristat Etiprate on the Pharmacokinetics of Single-dose Fexofenadine, a Sensitive P Glycoprotein Substrate, in Healthy Male and Female Subjects', 'orgStudyIdInfo': {'id': 'LX1606.1-106-NRM'}, 'secondaryIdInfos': [{'id': 'LX1606.106', 'type': 'OTHER', 'domain': 'Lexicon Pharmaceuticals, Inc.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All subjects', 'description': 'All subjects will receive a single oral dose of fexofenadine on Day 1 while fasting. Days 2 to 5 will be Washout days. On Day 6, subjects will begin a 5 day telotristat etiprate regimen. On Day 10 subjects will be given the morning telotristat etiprate dose concomitantly with a single dose of fexofenadine while fasting.', 'interventionNames': ['Drug: Fexofenadine', 'Drug: Telotristat etiprate']}], 'interventions': [{'name': 'Fexofenadine', 'type': 'DRUG', 'description': 'All subjects will receive 180 mg fexofenadine', 'armGroupLabels': ['All subjects']}, {'name': 'Telotristat etiprate', 'type': 'DRUG', 'description': 'All subjects will receive 500 mg (2 X 250 mg tablets) telotristat etiprate tablets three times daily', 'armGroupLabels': ['All subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Lexicon Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Suman Wason, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lexicon Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lexicon Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}