Status:
COMPLETED
A Safety, Tolerability, PD and PK Study in Healthy Adults
Lead Sponsor:
Trevena Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief 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 (...
Detailed Description
This will be conducted in two-parts enrolling a total of approximately 72 healthy volunteers. * Part A will assess the safety, tolerability, PD and PK of a 125mg dose of TRV734 in an open-label, rand...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT02211625
Start Date
July 1 2014
End Date
October 1 2014
Last Update
December 5 2014
Active Locations (1)
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1
ICON Development Solutions
San Antonio, Texas, United States, 78209