A Pharmacokinetic, Safety and Tolerability Study in Healthy Adult Males

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: TRV734

• Registration Number: NCT02411500
• Lead Sponsor: Trevena Inc.

Brief Summary

The primary objective of this study is to evaluate the pharmacokinetics of various TRV734 formulations in healthy male subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Study First Submitted: 2015-03-04
• Study First Submitted QC: 2015-04-03
• Study First Posted: 2015-04-08
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-17
• Last Update Posted: 2015-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

• Healthy as determined by a responsible physician or trained qualified designee
• Males: 18 - 55 years inclusive at screening
• Capable of giving written informed consent

Exclusion Criteria

• Clinically significant conditions or history of fainting or syncope
• Medical or psychiatric illness that could interfere with the completion of treatment and follow up
• Major surgery within 4-weeks of screening
• Known difficulty with obtaining intravenous access
• History of sensitivity to the study medication, or intolerance to opioids, or a history of medication or other allergy that contraindicates their participation
• Use of prescription or non-prescription medications
• History of excessive alcohol use
• History of drug abuse within 6 months of screening
• Use of any illegal drug within 30 days of screening and throughout participation in the study
• History of smoking or use of nicotine containing products within 3 months of screening and throughout participation in the study
• Donation of blood or plasma 4 weeks prior to dosing
• Participation in a clinical trial and has received medication within 30 days
• Weight <50 kg or BMI outside range of 18-32 kg/m2
• Positive for HIV antibody, hepatitis B virus surface antigen, or hepatitis C virus
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Formulation A	TRV734	-
Formulation B	TRV734	-
Formulation C	TRV734	-
Formulation D	TRV734	-
Formulation E	TRV734	-
Formulation F	TRV734	-

Primary Outcome Measures

Name	Time	Method
Evaluate the maximum observed plasma concentration (Cmax)	9-days
Evaluate the apparent clearance (CL/F)	9-days
Evaluate the time at which the maximum plasma concentration was observed (tmax)	9-days
Evaluate the area under the plasma concentration-time curve from time 0 to the last measurable plasma concentration (AUC0-t)	9-days
Evaluate the area under the plasma concentration-time curve from time 0 to time extrapolated to infinity (AUC0-inf)	9-days
Evaluate the apparent elimination half-life (t1/2)	9-days

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability as measured by clinical observations	9-days
Safety and tolerability as measured by vital signs (BP, HR, RR and oral temperature)	9-days
Safety and tolerability as measured by 12-lead ECGs	9-days
Safety and tolerability as measured by cardiac telemetry monitoring	9-days
Safety and tolerability as measured by adverse events	9-days
Safety and tolerability as measured by oxygen saturation	9-days
Safety and tolerability as measured by safety laboratory tests	9-days