Single Ascending Dose Study of Intravenous TRV130A in Healthy Adult Males

Completed · Phase 1

Conditions studied: Healthy

In brief

This study will evaluate the safety, blood levels, and effects of TRV130A on pain perception and sedation in healthy adult males.

Key facts

Study ID

NCT01514578

Run by

Trevena Inc.

People needed

74

Starts

2012-01-01

Expected to finish

2012-07-01

Last updated by the study team

2012-08-24

Who can join

Age: 19 and older, up to 50. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Healthy adult male 19 - 50 years of age
• Body weight >/= 50 kg
• Capable of giving written informed consent

You may not qualify if…

• 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

Where it is running

• ICON Development Solutions — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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