A Pharmacokinetic, Safety and Tolerability Study in Healthy Adult Males
- 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
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