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

NCT02083315 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-03-11

No results posted yet for this study

Summary

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

Conditions

  • Pain, Acute

Interventions

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

Sponsors & Collaborators

  • Trevena Inc.

    lead INDUSTRY

Principal Investigators

  • David G Soergel, MD · Trevena Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02083315 on ClinicalTrials.gov