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

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.

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

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