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

March 7, 2014 updated by: Trevena Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • CRI Lifetree

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Informed consent
  • Healthy adult males age 18 - 50 years, BMI 19-32 kg/m2
  • Acceptable duration of cold pain test results at screening

Exclusion Criteria:

  • Clinically significant medical illness or physical exam findings
  • Active dermatological conditions or skin trauma on the non-dominant hand, or peripheral vascular disease
  • Partial blindness, keratoconus, nystagmus or any other ophthalmic condition which could interfere with pupillometry
  • Use of tobacco or nicotine within 6 months prior to screening
  • History of recent (within 6 months) drug or alcohol abuse, as defined in DSM-IV-TR

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TRV130 1.5 mg
TRV130 1.5 mg IV x 1 dose
Drug: TRV130 1.5 mg
TRV130 1.5 mg IV x 1 dose
Experimental: TRV130 3 mg
TRV130 3 mg IV x 1 dose
Drug: TRV130 3 mg
TRV130 3 mg IV x 1 dose
Experimental: TRV130 4.5 mg
TRV130 4.5 mg IV x 1 dose
Drug: TRV130 4.5 mg
TRV130 4.5 mg IV x 1 dose
Active Comparator: Morphine
Morphine 10 mg IV x 1 dose
Drug: Morphine 10 mg
Morphine 10 mg IV x 1 dose
Placebo Comparator: Placebo
Dextrose 5% in water IV x 1 dose
Drug: Placebo
Dextrose 5% in water IV x 1 dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cold Pain Test
Time Frame: 8 hours postdose
8 hours postdose

Secondary Outcome Measures

Outcome Measure
Time Frame
Ventilatory Response to Hypercapnia
Time Frame: 4 hours postdose
4 hours postdose
Pupillometry
Time Frame: 8 hours postdose
8 hours postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trevena Inc.

Investigators

  • Study Chair: David G Soergel, MD, Trevena Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

February 24, 2014

First Submitted That Met QC Criteria

March 7, 2014

First Posted (Estimate)

March 11, 2014

Study Record Updates

Last Update Posted (Estimate)

March 11, 2014

Last Update Submitted That Met QC Criteria

March 7, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP130-1003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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