Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-02-23 @ 12:22 PM
Study NCT ID:
NCT02344303
Status:
COMPLETED
Last Update Posted:
2017-05-12
First Post:
2015-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Effects of TRV130, at Therapeutic and Supra Therapeutic Doses, on QTc Intervals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C586842', 'term': '((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine'}, {'id': 'D000077266', 'term': 'Moxifloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-11', 'studyFirstSubmitDate': '2015-01-09', 'studyFirstSubmitQcDate': '2015-01-16', 'lastUpdatePostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A - Number of Participants with Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': 'Prior to dose through 4 hours'}, {'measure': 'Part B - Change from baseline in QTc', 'timeFrame': 'Prior to dose through 24 hours'}], 'secondaryOutcomes': [{'measure': 'Part B - Pharmacodynamics - QTc', 'timeFrame': 'Prior to dose through 24 hours', 'description': 'Including QTc, heart rate, PR interval, QRS interval, uncorrected QT interval, ECG morphology and correlation between the QTcF change from baseline and plasma concentrations of TRV130.'}, {'measure': 'Part B - Number of Participants with Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': 'Prior to dose through Follow-Up Visit', 'description': 'Adverse events reporting, clinical observations, 12- lead electrocardiograms, vital signs, respiratory rate, body temperature and safety laboratory tests'}, {'measure': 'Part A & B - Pharmacokinetics - Cmax, tmax, AUC', 'timeFrame': 'Prior to dose through 24 hours', 'description': 'Parameters will include (but not limited to): Cmax, tmax, AUC0-τ, z: (apparent terminal rate constant calculated from the regression analysis (slope) of the log-transformed measured concentrations on the terminal phase of the time)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Assess the electrocardiogram effects of TRV130 relative to placebo at therapeutic and supratherapeutic doses.', 'detailedDescription': '* Part A of the study will assess clinical safety data of TRV130\n* Part B of the study will assess the effect of single dose TRV130 on QTc'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and/or female subjects between the ages of 18 and 45 inclusive.\n* Women must be either a) post-menopausal; b) surgically sterile; c) of child-bearing potential and practicing contraception or remaining sexually inactive.\n* Men must be willing to abstain from sperm donation from the time of Screening through the Follow-up Visit and, if sexually active with a woman of child-bearing potential, must be protected by acceptable forms of effective contraception through the Follow-up Visit.\n\nExclusion Criteria:\n\n* Past or present diseases including, but not limited to, significant medical abnormalities including: psychiatric, neurologic, pulmonary, cardiac, gastrointestinal, genitourinary, renal, metabolic, endocrinologic or autoimmune disorders.\n* Has previously participated in another TRV130 clinical study.'}, 'identificationModule': {'nctId': 'NCT02344303', 'briefTitle': 'Study of the Effects of TRV130, at Therapeutic and Supra Therapeutic Doses, on QTc Intervals', 'organization': {'class': 'INDUSTRY', 'fullName': 'Trevena Inc.'}, 'officialTitle': 'A Single-dose, Open-label, Fixed Sequence, Two Period Cross Over Study to Assess the Tolerability of a Supra Therapeutic Dose of TRV130 Followed by A Single Dose, Randomized, Double Blind, Comparative, Positive and Placebo Controlled, Four Period Cross-over Study of the Effects of TRV130, at Therapeutic and Supra Therapeutic Doses, on the QTc Intervals in Healthy Subjects', 'orgStudyIdInfo': {'id': 'CP130-1008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A', 'description': 'Fixed sequence, open label', 'interventionNames': ['Drug: TRV130']}, {'type': 'EXPERIMENTAL', 'label': 'Part B', 'description': '4 way cross over, double blind', 'interventionNames': ['Drug: TRV130', 'Drug: Moxifloxacin', 'Drug: Placebo']}], 'interventions': [{'name': 'TRV130', 'type': 'DRUG', 'armGroupLabels': ['Part A', 'Part B']}, {'name': 'Moxifloxacin', 'type': 'DRUG', 'armGroupLabels': ['Part B']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Part B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21225', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Franck Skobieranda', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Trevena Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trevena Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}