Healthy
Conditions
Keywords
Healthy, Male, Pharmacokinetics
Brief summary
The primary objective of this study is to evaluate the pharmacokinetics of various TRV734 formulations in healthy male subjects.
Interventions
DRUGTRV734
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.
Sponsors
Trevena Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the maximum observed plasma concentration (Cmax) | 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 |
| Evaluate the apparent clearance (CL/F) | 9-days |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability as measured by adverse events | 9-days |
| Safety and tolerability as measured by safety laboratory tests | 9-days |
| Safety and tolerability as measured by clinical observations | 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 vital signs (BP, HR, RR and oral temperature) | 9-days |
| Safety and tolerability as measured by oxygen saturation | 9-days |
Countries
United States
Outcome results
None listed