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

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Trevena Inc.
• Treatments: Morphine

Criteria

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