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

NCT02211625 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2014-12-05

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Trevena Inc.

    lead INDUSTRY

Principal Investigators

  • Franck Skobieranda, MD · Trevena Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2014-10-31
Completion
2014-10-31

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 NCT02211625 on ClinicalTrials.gov