Single Ascending Dose Study of Intravenous TRV130A in Healthy Adult Males

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: TRV130A; Drug: Dextrose in Water

• Registration Number: NCT01514578
• Lead Sponsor: Trevena Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-17
• Study First Submitted QC: 2012-01-20
• Study First Posted: 2012-01-23
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-23
• Last Update Posted: 2012-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TRV130A	TRV130A	-
Dextrose in Water	Dextrose in Water	-

Primary Outcome Measures

Name	Time	Method
Number of subjects with adverse events	Baseline to 8 days after dose administration
Area under the plasma concentration versus time curve of TRV130A	Baseline to 24 hours after dose administration

Secondary Outcome Measures

Name	Time	Method
Effect of TRV130A on pain perception using cold pain test	Baseline to 3 hours after dose administration
Effect of TRV130A on pupil diameter	Baseline to 3 hours after dose administration
Effect of TRV130A on eye movements	Baseline to 3 hours after dose administration	Using saccadic eye movement measurement
Effect of TRV130A on sedation	Baseline to 3 hours after dose administration	Sedation evaluated by questionnaire

Trial Locations

Locations (1)

ICON Development Solutions; 🇺🇸 Omaha, Nebraska, United States