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Single Ascending Dose Study of Intravenous TRV130A in Healthy Adult Males

This study has been completed.
Information provided by (Responsible Party):
Trevena Inc. Identifier:
First received: January 17, 2012
Last updated: August 23, 2012
Last verified: August 2012
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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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

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 ]
  • Area under the plasma concentration versus time curve of TRV130A [ Time Frame: Baseline to 24 hours after dose administration ]

Secondary Outcome Measures:
  • Effect of TRV130A on pain perception using cold pain test [ Time Frame: Baseline to 3 hours after dose administration ]
  • Effect of TRV130A on pupil diameter [ Time Frame: Baseline to 3 hours after dose administration ]
  • Effect of TRV130A on eye movements [ Time Frame: Baseline to 3 hours after dose administration ]
    Using saccadic eye movement measurement

  • Effect of TRV130A on sedation [ Time Frame: Baseline to 3 hours after dose administration ]
    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


Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01514578

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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Trevena Inc. Identifier: NCT01514578     History of Changes
Other Study ID Numbers: CP130-1001
Study First Received: January 17, 2012
Last Updated: August 23, 2012

Keywords provided by Trevena Inc.:
TRV130A processed this record on September 25, 2017