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

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2013

Detailed Description

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

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

Arms, Groups and Cohorts

  • Experimental: TRV130 1.5 mg
    • TRV130 1.5 mg IV x 1 dose
  • Experimental: TRV130 3 mg
    • TRV130 3 mg IV x 1 dose
  • Experimental: TRV130 4.5 mg
    • TRV130 4.5 mg IV x 1 dose
  • Active Comparator: Morphine
    • Morphine 10 mg IV x 1 dose
  • Placebo Comparator: Placebo
    • Dextrose 5% in water IV x 1 dose

Clinical Trial Outcome Measures

Primary Measures

  • Cold Pain Test
    • Time Frame: 8 hours postdose

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Trevena Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • David G Soergel, MD, Study Chair, Trevena Inc.

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