NCT02083315

Pharmacokinetics and Pharmacodynamics of TRV130, Morphine, and Placebo in Healthy Subjects

A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Explore the Pharmacokinetics and Pharmacodynamics of TRV130, Morphine, and Placebo in Healthy Adult Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Trevena Inc. · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study is designed to compare TRV130 to placebo and morphine to learn about its effects on pain relief and side effects.

Detailed description

This study will explore the pharmacokinetics, pharmacodynamics (PD), safety and tolerability of TRV130.

Conditions

• Pain, Acute

Interventions

Type	Name	Description
DRUG	TRV130 1.5 mg	TRV130 1.5 mg IV x 1 dose
DRUG	TRV130 3 mg	TRV130 3 mg IV x 1 dose
DRUG	TRV130 4.5 mg	TRV130 4.5 mg IV x 1 dose
DRUG	Morphine 10 mg	Morphine 10 mg IV x 1 dose
DRUG	Placebo	Dextrose 5% in water IV x 1 dose

Timeline

• Start date: 2013-07-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2014-03-11
• Last updated: 2014-03-11

Locations

1 site across 1 country: United States