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Completed

NCT Number: NCT01514578

Single Ascending Dose Study of Intravenous TRV130A in Healthy Adult Males

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

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Key information

Conditions

Healthy

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

ICON Development Solutions

Omaha, Nebraska, 68154, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TRV130A

Drug

Intravenous infusion of 1 hour duration

Dextrose in Water

Drug

Intravenous infusion of 1 hour duration

Primary outcomes

  1. Number of subjects with adverse events

    Time frame: Baseline to 8 days after dose administration

  2. Area under the plasma concentration versus time curve of TRV130A

    Time frame: Baseline to 24 hours after dose administration

Secondary outcomes

  1. Effect of TRV130A on pain perception using cold pain test

    Time frame: Baseline to 3 hours after dose administration

  2. Effect of TRV130A on pupil diameter

    Time frame: Baseline to 3 hours after dose administration

  3. Effect of TRV130A on eye movements

    Time frame: Baseline to 3 hours after dose administration

    Using saccadic eye movement measurement

  4. Effect of TRV130A on sedation

    Time frame: Baseline to 3 hours after dose administration

    Sedation evaluated by questionnaire

Sponsors and collaborators

Lead sponsor

Trevena Inc.

Industry

Registry information

Official study title

A Multi-Part, Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous TRV130A in Healthy Adult Males

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 23, 2012
Registry last updated
Aug 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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