NCT01514578

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jan 2012

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

August 24, 2012

Status Verified

August 1, 2012

Enrollment Period

6 months

First QC Date

January 17, 2012

Last Update Submit

August 23, 2012

Conditions

Healthy

Keywords

safetytolerabilityTRV130A

Outcome Measures

Primary Outcomes (2)

  • Number of subjects with adverse events

    Baseline to 8 days after dose administration

  • Area under the plasma concentration versus time curve of TRV130A

    Baseline to 24 hours after dose administration

Secondary Outcomes (4)

  • Effect of TRV130A on pain perception using cold pain test

    Baseline to 3 hours after dose administration

  • Effect of TRV130A on pupil diameter

    Baseline to 3 hours after dose administration

  • Effect of TRV130A on eye movements

    Baseline to 3 hours after dose administration

  • Effect of TRV130A on sedation

    Baseline to 3 hours after dose administration

Study Arms (2)

TRV130A

EXPERIMENTAL
Drug: TRV130A

Dextrose in Water

PLACEBO COMPARATOR
Drug: Dextrose in Water

Interventions

TRV130ADRUG

Intravenous infusion of 1 hour duration

TRV130A
Dextrose in WaterDRUG

Intravenous infusion of 1 hour duration

Dextrose in Water

Eligibility Criteria

Age19 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult male 19 - 50 years of age
  • Body weight \>/= 50 kg
  • Capable of giving written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICON Development Solutions

Omaha, Nebraska, 68154, United States

Location

Related Publications (2)

  • Soergel DG, Subach RA, Sadler B, Connell J, Marion AS, Cowan CL, Violin JD, Lark MW. First clinical experience with TRV130: pharmacokinetics and pharmacodynamics in healthy volunteers. J Clin Pharmacol. 2014 Mar;54(3):351-7. doi: 10.1002/jcph.207. Epub 2014 Jan 28.

    PMID: 24122908DERIVED

  • 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.

    PMID: 23813302DERIVED

MeSH Terms

Interventions

GlucoseWater

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • David G. Soergel, MD

    Trevena Inc.

    STUDY DIRECTOR

  • Alan S. Marion, MD, PhD

    ICON Development Solutions

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2012

First Posted

January 23, 2012

Study Start

January 1, 2012

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

August 24, 2012

Record last verified: 2012-08

Locations

US(1)