Single Ascending Dose Study of Intravenous TRV130A in Healthy Adult Males

Trevena

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: TRV130A; Drug: Dextrose in Water

Study type: Interventional

Funder types: Industry

Identifiers

NCT01514578

CP130-1001

Details and patient eligibility

About

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

Enrollment: 74 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups, including a placebo group

TRV130A

Experimental group

Treatment:

Drug: TRV130A

Dextrose in Water

Placebo Comparator group

Treatment:

Drug: Dextrose in Water