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A Study to Investigate the Metabolism and Excretion of [14C]-TRV130 in Healthy Male Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02169934
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : November 18, 2015
Sponsor:
Information provided by (Responsible Party):
Trevena Inc.

Brief Summary:
The purpose of this study is to determine the routes of excretion for TRV130 and it's metabolites, and to determine and characterize, structurally, the metabolites present in plasma, urine, and feces in healthy male subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: Radiolabeled TRV130 Phase 1

Detailed Description:
This study is an open-label, non-randomized, metabolism and excretion study of a single 2 mg IV dose of [14C] TRV130 (approximately 100 µCi) administered as a 10 mL manual IV push over 2 minutes in a fasted state.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Investigate the Metabolism and Excretion of [14C]-TRV130 Following Single Intravenous Dose Administration in Healthy Male Subjects
Study Start Date : June 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : May 2015

Arm Intervention/treatment
Experimental: Radiolabeled TRV130 Drug: Radiolabeled TRV130
A single 2 mg IV dose administered as a 10 mL manual IV push over 2 minutes




Primary Outcome Measures :
  1. To assess the pharmacokinetics (PK) of a single IV dose of [14C]-TRV130 [ Time Frame: Day 1 - Day 13 ]
  2. To determine plasma concentrations of total radioactivity [ Time Frame: Day 1 - Day 13 ]
  3. To determine whole blood concentrations of total radioactivity [ Time Frame: Day 1 - Day 13 ]
  4. To determine urine concentrations of total radioactivity [ Time Frame: Day 1 - Day 13 ]
  5. To determine fecal concentration of total radioactivity [ Time Frame: Day 1 - Day 13 ]

Secondary Outcome Measures :
  1. To identify metabolites associated with TRV130 in blood, urine and feces [ Time Frame: Day 1 - Day 13 ]
  2. Number of patients experiencing an Adverse Event [ Time Frame: Day 1 - Day 13 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • Males, between 18 and 64 years of age, inclusive
  • With body weight ≥ 50 kg and body mass index (BMI) between 18 and 32 kg/m2, inclusive
  • In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
  • Negative test for selected drugs of abuse at Screening and at Check-in
  • Able to comprehend and willing to sign an Informed Consent Form (ICF) prior to any study procedure
  • A typical minimum of 1 to 2 bowel movements per day

Key Exclusion Criteria:

  • History of sensitivity to any of the study medications or components thereof or a history of medication or other allergy that, in the opinion of the Investigator, contraindicates their participation
  • Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 28 days prior to Check-in
  • Participation in any other radiolabeled investigational study drug trial within 12 months prior to Check-in
  • Exposure to significant radiation (eg, serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) within 12 months prior to Check-in
  • Has current malignancy, current systemic chemotherapy, or cancer diagnosis within 5 years prior to Screening (excluding squamous or basal cell carcinoma of the skin that has been clinically stable and fully excised in a curative procedure);
  • Use of any tobacco- or nicotine-containing products within 6 months prior to Screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169934


Locations
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United States, Wisconsin
Madison Clinical Research Unit
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Trevena Inc.
Investigators
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Study Director: Trevena Inc Trevena Inc.
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Responsible Party: Trevena Inc.
ClinicalTrials.gov Identifier: NCT02169934    
Other Study ID Numbers: CP130-1007
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: November 2015