Ignite Creation Date:
2025-12-24 @ 10:39 PM
Ignite Modification Date:
2026-01-01 @ 7:47 PM
Study NCT ID:
NCT02195635
Status:
COMPLETED
Last Update Posted:
2016-09-07
First Post:
2014-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1, Open-label, Drug-drug Interaction Study With Octreotide Acetate Injection and Telotristat Etiprate in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000592493', 'term': 'telotristat'}, {'id': 'D015282', 'term': 'Octreotide'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'lastUpdateSubmitDate': '2016-09-06', 'studyFirstSubmitDate': '2014-07-17', 'studyFirstSubmitQcDate': '2014-07-17', 'lastUpdatePostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma concentrations of telotristat ethyl', 'timeFrame': 'Days 1, 2, 3, 6, 7, 8'}, {'measure': 'Plasma concentrations of metabolite LP-778902', 'timeFrame': 'Days 1, 2, 3, 6, 7, 8'}], 'secondaryOutcomes': [{'measure': 'Number of treatment-emergent adverse events', 'timeFrame': 'Up to 39 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Drug Interactions']}, 'descriptionModule': {'briefSummary': 'To evaluate the effect of octreotide acetate injections (200 µg 3 times daily \\[tid\\]) on the pharmacokinetics (PK) of telotristat ethyl and its metabolite LP-778902 relative to administration of single-dose telotristat etiprate in healthy male and female subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy males or females ≥18 to ≤55 years of age\n* Body mass index 18.0 to 32.0 kg/m2, inclusive, at Screening\n* Vital signs (after at least 5 minutes resting in a supine position) at Screening that are within the following ranges: Systolic blood pressure, 90 to 140 mm Hg; Diastolic blood pressure, 50 to 90 mm Hg; Heart rate 40 to 100 beats per minute (bpm)\n* Willing to adhere to the prohibitions and restrictions specified in this protocol\n* Able to comprehend and willing to sign an Informed Consent Form\n\nExclusion Criteria:\n\n* Presence of clinically significant physical, laboratory, or electrocardiogram (ECG) findings at Screening or Check-in (Day 1) that, in the opinion of the Investigator and/or the Sponsor or Sponsor's representative, may interfere with any aspect of study conduct or interpretation of results\n* Use of any medications (prescription or over-the-counter), herbal tea, energy drinks, herbal products (eg, St. John's Wort, garlic, milk thistle, etc.), or supplements/supratherapeutic doses of vitamins within 14 days prior to the first dose administration and throughout the duration of the study, with the exception of those approved by the Investigator and/or the Sponsor or Sponsor's representative\n* Prior exposure to telotristat etiprate\n* Use of tobacco, smoking cessation products, or products containing nicotine within 3 months prior to Screening and for the duration of the study\n* History of any major surgery within 6 months prior to Screening\n* History of renal disease\n* History of hepatic disease, or significantly abnormal liver function tests (\\>1.5 x upper limit of normal \\[ULN\\])\n* History of gall bladder abnormalities\n* History of any endocrine disorder\n* History of alcohol or substance abuse within 2 years prior to Screening\n* Positive urine screen for drugs of abuse and cotinine\n* Consumption of caffeine- and/or xanthine containing products (eg, cola, coffee, tea, chocolate) within 72 hours prior to Check-in\n* Consumption of alcohol within 48 hours prior to Check in\n* Consumption of grapefruit, Seville oranges, and grapefruit- or Seville orange containing products within 72 hours prior to Check in"}, 'identificationModule': {'nctId': 'NCT02195635', 'briefTitle': 'Phase 1, Open-label, Drug-drug Interaction Study With Octreotide Acetate Injection and Telotristat Etiprate 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 Octreotide Acetate Injection (Sandostatin®) on the Pharmacokinetics of Single-dose Telotristat Etiprate in Healthy Male and Female Subjects', 'orgStudyIdInfo': {'id': 'LX1606.1-109-NRM'}, 'secondaryIdInfos': [{'id': 'LX1606.109', 'type': 'OTHER', 'domain': 'Lexicon Pharmaceuticals, Inc.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Period 1', 'description': 'Single oral dose of 500 mg telotristat etiprate on Day 1', 'interventionNames': ['Drug: Telotristat etiprate']}, {'type': 'OTHER', 'label': 'Period 2', 'description': 'Subcutaneous injections of 200 µg octreotide acetate three times daily with a single oral dose of 500 mg telotristat etiprate on Day 6', 'interventionNames': ['Drug: Telotristat etiprate', 'Drug: Octreotide acetate']}], 'interventions': [{'name': 'Telotristat etiprate', 'type': 'DRUG', 'description': '500 mg telotristat etiprate', 'armGroupLabels': ['Period 1', 'Period 2']}, {'name': 'Octreotide acetate', 'type': 'DRUG', 'description': '200 µg octreotide acetate three times daily', 'armGroupLabels': ['Period 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Lexicon Investigational Site', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}], 'overallOfficials': [{'name': 'Suman Wason, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lexicon Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lexicon Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}