A Pharmacokinetic, Safety and Tolerability Study in Healthy Adult Males
Completed · Phase 1
Conditions studied: Healthy
In brief
The primary objective of this study is to evaluate the pharmacokinetics of various TRV734 formulations in healthy male subjects.
Key facts
- Study ID
- NCT02411500
- Run by
- Trevena Inc.
- People needed
- 18
- Starts
- 2015-02-01
- Expected to finish
- 2015-03-01
- Last updated by the study team
- 2015-11-18
Who can join
Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- Healthy as determined by a responsible physician or trained qualified designee
- Males: 18 - 55 years inclusive at screening
- Capable of giving written informed consent
You may not qualify if…
- 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
Where it is running
- Study site — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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