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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
History of Changes
  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:

MedlinePlus related topics: Drinking Water
Drug Information available for: Dextrose
U.S. FDA Resources

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:
ICON Development Solutions  This link exits the ClinicalTrials.gov site

No publications provided

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 May 16, 2013