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

January 17, 2012
August 23, 2012
January 2012
July 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01514578 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Single Ascending Dose Study of Intravenous TRV130A in Healthy Adult Males
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Healthy
  • Drug: TRV130A
    Intravenous infusion of 1 hour duration
  • Drug: Dextrose in Water
    Intravenous infusion of 1 hour duration
  • Experimental: TRV130A
    Intervention: Drug: TRV130A
  • Placebo Comparator: Dextrose in Water
    Intervention: Drug: Dextrose in Water
Soergel DG, Subach RA, Cowan CL, Violin JD, Lark MW. First clinical experience with TRV027: pharmacokinetics and pharmacodynamics in healthy volunteers. J Clin Pharmacol. 2013 Sep;53(9):892-9. doi: 10.1002/jcph.111. Epub 2013 Jun 29. PubMed PMID: 23813302.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Male
19 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01514578
CP130-1001
Yes
Trevena Inc.
Trevena Inc.
Not Provided
Study Director: David G. Soergel, MD Trevena Inc.
Principal Investigator: Alan S. Marion, MD, PhD ICON Development Solutions
Trevena Inc.
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP