NCT02211625

A Safety, Tolerability, PD and PK Study in Healthy Adults

A Two-Part Study to Evaluate the Safety, Tolerability, Pharmacodynamics And Pharmacokinetics of TRV734 in Healthy Adult Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Trevena Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of TRV734 given as a single dose (Part A) and as multiple ascending doses (Part B) in healthy subjects.

Detailed description

This will be conducted in two-parts enrolling a total of approximately 72 healthy volunteers. * Part A will assess the safety, tolerability, PD and PK of a 125mg dose of TRV734 in an open-label, randomized, three-period crossover study in which subjects are fasted, fed a standard meal, or fed a high-fat meal. * Part B of the trial will assess the safety, tolerability, PD and PK of multiple ascending doses of TRV734 in a double blind, double dummy, randomized, active- and placebo-controlled, adaptive study. Oxycodone immediate release (IR) 10 mg will be used as a benchmark.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Open-label TRV734 125 mg	125 mg
DRUG	TRV734 blinded	blinded, multiple ascending dose
DRUG	Oxycodone IR 10 mg
DRUG	Placebo	TRV734-matched and oxycodone placebo

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-08-07
• Last updated: 2014-12-05

Locations

1 site across 1 country: United States