Status:
COMPLETED
Single Ascending Dose Study of Intravenous TRV130A in Healthy Adult Males
Lead Sponsor:
Trevena Inc.
Conditions:
Healthy
Eligibility:
MALE
19-50 years
Phase:
PHASE1
Brief Summary
This study will evaluate the safety, blood levels, and effects of TRV130A on pain perception and sedation in healthy adult males.
Eligibility Criteria
Inclusion
- Healthy adult male 19 - 50 years of age
- Body weight \>/= 50 kg
- Capable of giving written informed consent
Exclusion
- Clinically significant disease or conditions that may place the subject at unacceptable risk as a participant in the study, or that may interfere with the safety, tolerability or pharmacodynamic evaluations in the study
- Laboratory tests positive for HIV, Hepatitis B virus surface antigen, or Hepatitis C virus antibody; elevations of aspartate aminotransferase or alanine aminotransferase; positive drug or alcohol test; positive urine test for cotinine
- Major surgery within 4 weeks of screening
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT01514578
Start Date
January 1 2012
End Date
July 1 2012
Last Update
August 24 2012
Active Locations (1)
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1
ICON Development Solutions
Omaha, Nebraska, United States, 68154