Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2026-02-27 @ 3:13 AM
Study NCT ID:
NCT02411500
Status:
COMPLETED
Last Update Posted:
2015-11-18
First Post:
2015-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pharmacokinetic, Safety and Tolerability Study in Healthy Adult Males
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-17', 'studyFirstSubmitDate': '2015-03-04', 'studyFirstSubmitQcDate': '2015-04-03', 'lastUpdatePostDateStruct': {'date': '2015-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the maximum observed plasma concentration (Cmax)', 'timeFrame': '9-days'}, {'measure': 'Evaluate the time at which the maximum plasma concentration was observed (tmax)', 'timeFrame': '9-days'}, {'measure': 'Evaluate the area under the plasma concentration-time curve from time 0 to the last measurable plasma concentration (AUC0-t)', 'timeFrame': '9-days'}, {'measure': 'Evaluate the area under the plasma concentration-time curve from time 0 to time extrapolated to infinity (AUC0-inf)', 'timeFrame': '9-days'}, {'measure': 'Evaluate the apparent elimination half-life (t1/2)', 'timeFrame': '9-days'}, {'measure': 'Evaluate the apparent clearance (CL/F)', 'timeFrame': '9-days'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability as measured by adverse events', 'timeFrame': '9-days'}, {'measure': 'Safety and tolerability as measured by clinical observations', 'timeFrame': '9-days'}, {'measure': 'Safety and tolerability as measured by 12-lead ECGs', 'timeFrame': '9-days'}, {'measure': 'Safety and tolerability as measured by cardiac telemetry monitoring', 'timeFrame': '9-days'}, {'measure': 'Safety and tolerability as measured by vital signs (BP, HR, RR and oral temperature)', 'timeFrame': '9-days'}, {'measure': 'Safety and tolerability as measured by oxygen saturation', 'timeFrame': '9-days'}, {'measure': 'Safety and tolerability as measured by safety laboratory tests', 'timeFrame': '9-days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy', 'Male', 'Pharmacokinetics'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the pharmacokinetics of various TRV734 formulations in healthy male subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy as determined by a responsible physician or trained qualified designee\n* Males: 18 - 55 years inclusive at screening\n* Capable of giving written informed consent\n\nExclusion Criteria:\n\n* Clinically significant conditions or history of fainting or syncope\n* Medical or psychiatric illness that could interfere with the completion of treatment and follow up\n* Major surgery within 4-weeks of screening\n* Known difficulty with obtaining intravenous access\n* History of sensitivity to the study medication, or intolerance to opioids, or a history of medication or other allergy that contraindicates their participation\n* Use of prescription or non-prescription medications\n* History of excessive alcohol use\n* History of drug abuse within 6 months of screening\n* Use of any illegal drug within 30 days of screening and throughout participation in the study\n* History of smoking or use of nicotine containing products within 3 months of screening and throughout participation in the study\n* Donation of blood or plasma 4 weeks prior to dosing\n* Participation in a clinical trial and has received medication within 30 days\n* Weight \\<50 kg or BMI outside range of 18-32 kg/m2\n* Positive for HIV antibody, hepatitis B virus surface antigen, or hepatitis C virus\n* Unwillingness to abstain from sexual intercourse with a pregnant or lactating woman and, if engaging in sexual intercourse with a female partner of child-bearing potential, use a condom and spermicide, in addition to having their female partner use another form of contraception, and abstain from sperm donation'}, 'identificationModule': {'nctId': 'NCT02411500', 'briefTitle': 'A Pharmacokinetic, Safety and Tolerability Study in Healthy Adult Males', 'organization': {'class': 'INDUSTRY', 'fullName': 'Trevena Inc.'}, 'officialTitle': 'A Randomized, Open Label, Four Period, Cross-Over Study to Evaluate the Pharmacokinetics of Single Doses of Various TRV734 Formulations in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'CP734-1003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Formulation A', 'interventionNames': ['Drug: TRV734']}, {'type': 'EXPERIMENTAL', 'label': 'Formulation B', 'interventionNames': ['Drug: TRV734']}, {'type': 'EXPERIMENTAL', 'label': 'Formulation C', 'interventionNames': ['Drug: TRV734']}, {'type': 'EXPERIMENTAL', 'label': 'Formulation D', 'interventionNames': ['Drug: TRV734']}, {'type': 'EXPERIMENTAL', 'label': 'Formulation E', 'interventionNames': ['Drug: TRV734']}, {'type': 'EXPERIMENTAL', 'label': 'Formulation F', 'interventionNames': ['Drug: TRV734']}], 'interventions': [{'name': 'TRV734', 'type': 'DRUG', 'description': 'Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion. Days 2, 4, 6 and 8 are designated as washout days.', 'armGroupLabels': ['Formulation A', 'Formulation B', 'Formulation C', 'Formulation D', 'Formulation E', 'Formulation F']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trevena Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}