A Safety, Tolerability, PD and PK Study in Healthy Adults

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of TRV734 given as a single dose (Part A) and as multiple ascending doses (Part B) in healthy subjects.

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

Details

• Lead Sponsor: Trevena Inc.
• Treatments: Oxycodone

Criteria

Inclusion Criteria:

• Healthy as determined by a responsible physician or trained qualified designee

• Males (Part A) or males and females (Part B) between 18 & 64 years of age, inclusive. Females must be of non-childbearing

• Capable of giving written informed consent

Exclusion Criteria:

• Clinically significant conditions, or history of fainting or syncope

• Medical or psychiatric illness

• Major surgery within 4 weeks of screening

• Known difficulty with obtaining intravenous access

• Any ophthalmologic condition that could interfere with pupillometry

• History of sensitivity to any of the investigational products, or known intolerance to opioids or a history of medication or other allergy

• Use of prescription or non prescription medications

• 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 within 4 weeks prior to dosing

• Participation in a clinical trial and has received a 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

• If male, unwillingness to abstain from sexual intercourse with a pregnant or lactating woman and, if engaging in sexual intercourse with a female partner of childbearing potential, use a condom and spermicide, in addition to having their female partner use another form of contraception, and abstain from sperm donation

• Part B Only:

• Active dermatological condition or eczema on non-dominant hand.

• Peripheral vascular disease

• If female, of child bearing potential, pregnant or breastfeeding