Single Ascending Dose Study of Intravenous TRV130A in Healthy Adult Males

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Trevena Inc.
ClinicalTrials.gov Identifier:
NCT01514578
First received: January 17, 2012
Last updated: August 23, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Healthy
Drug: TRV130A
Drug: Dextrose in Water
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Trevena Inc.:

Primary Outcome Measures:
  • Number of subjects with adverse events [ Time Frame: Baseline to 8 days after dose administration ] [ Designated as safety issue: Yes ]
  • Area under the plasma concentration versus time curve of TRV130A [ Time Frame: Baseline to 24 hours after dose administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of TRV130A on pain perception using cold pain test [ Time Frame: Baseline to 3 hours after dose administration ] [ Designated as safety issue: No ]
  • Effect of TRV130A on pupil diameter [ Time Frame: Baseline to 3 hours after dose administration ] [ Designated as safety issue: No ]
  • Effect of TRV130A on eye movements [ Time Frame: Baseline to 3 hours after dose administration ] [ Designated as safety issue: No ]
    Using saccadic eye movement measurement

  • Effect of TRV130A on sedation [ Time Frame: Baseline to 3 hours after dose administration ] [ Designated as safety issue: No ]
    Sedation evaluated by questionnaire


Enrollment: 74
Study Start Date: January 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TRV130A Drug: TRV130A
Intravenous infusion of 1 hour duration
Placebo Comparator: Dextrose in Water Drug: Dextrose in Water
Intravenous infusion of 1 hour duration

  Eligibility

Ages Eligible for Study:   19 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514578

Locations
United States, Nebraska
ICON Development Solutions
Omaha, Nebraska, United States, 68154
Sponsors and Collaborators
Trevena Inc.
Investigators
Study Director: David G. Soergel, MD Trevena Inc.
Principal Investigator: Alan S. Marion, MD, PhD ICON Development Solutions
  More Information

Additional Information:
No publications provided by Trevena Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Trevena Inc.
ClinicalTrials.gov Identifier: NCT01514578     History of Changes
Other Study ID Numbers: CP130-1001
Study First Received: January 17, 2012
Last Updated: August 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Trevena Inc.:
safety
tolerability
TRV130A

ClinicalTrials.gov processed this record on April 23, 2014