A Pharmacokinetic, Safety and Tolerability Study in Healthy Adult Males

A Randomized, Open Label, Four Period, Cross-Over Study to Evaluate the Pharmacokinetics of Single Doses of Various TRV734 Formulations in Healthy Male Subjects

The primary objective of this study is to evaluate the pharmacokinetics of various TRV734 formulations in healthy male subjects.

Inclusion Criteria:

• Healthy as determined by a responsible physician or trained qualified designee
• Males: 18 - 55 years inclusive at screening
• Capable of giving written informed consent

Exclusion Criteria:

• Clinically significant conditions or history of fainting or syncope
• Medical or psychiatric illness that could interfere with the completion of treatment and follow up
• Major surgery within 4-weeks of screening
• Known difficulty with obtaining intravenous access
• History of sensitivity to the study medication, or intolerance to opioids, or a history of medication or other allergy that contraindicates their participation
• Use of prescription or non-prescription medications
• History of excessive alcohol use
• History of drug abuse within 6 months of screening
• Use of any illegal drug within 30 days of screening and throughout participation in the study
• History of smoking or use of nicotine containing products within 3 months of screening and throughout participation in the study
• Donation of blood or plasma 4 weeks prior to dosing
• Participation in a clinical trial and has received medication within 30 days
• Weight <50 kg or BMI outside range of 18-32 kg/m2
• Positive for HIV antibody, hepatitis B virus surface antigen, or hepatitis C virus
• Unwillingness to abstain from sexual intercourse with a pregnant or lactating woman and, if engaging in sexual intercourse with a female partner of child-bearing potential, use a condom and spermicide, in addition to having their female partner use another form of contraception, and abstain from sperm donation