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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02211625

Run by

Trevena Inc.

People needed

75

Starts

2014-07-01

Expected to finish

2014-10-01

Last updated by the study team

2014-12-05

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• ICON Development Solutions — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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