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OpenTrials
Completed

NCT Number: NCT02083315

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

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

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Key information

Conditions

Pain, Acute Acute Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CRI Lifetree

Salt Lake City, Utah, 84106, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TRV130 1.5 mg

Drug

TRV130 1.5 mg IV x 1 dose

TRV130 3 mg

Drug

TRV130 3 mg IV x 1 dose

TRV130 4.5 mg

Drug

TRV130 4.5 mg IV x 1 dose

Morphine 10 mg

Drug

Morphine 10 mg IV x 1 dose

Placebo

Drug

Dextrose 5% in water IV x 1 dose

Primary outcomes

  1. Cold Pain Test

    Time frame: 8 hours postdose

Secondary outcomes

  1. Ventilatory Response to Hypercapnia

    Time frame: 4 hours postdose

  2. Pupillometry

    Time frame: 8 hours postdose

Sponsors and collaborators

Lead sponsor

Trevena Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 11, 2014
Registry last updated
Mar 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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