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

Pain, Acute Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02083315
• Other study ID #: CP130-1003
• Status: Completed
• Phase: Phase 1
• First received: February 24, 2014
• Last updated: March 7, 2014
• Start date: July 2013
• Est. completion date: August 2013

Study information

• Verified date: March 2014
• Source: Trevena Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Acute

Intervention

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

Locations

Country	Name	City	State
United States	CRI Lifetree	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Trevena Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cold Pain Test		8 hours postdose	No
Secondary	Ventilatory Response to Hypercapnia		4 hours postdose	Yes
Secondary	Pupillometry		8 hours postdose	No