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Completed

NCT Number: NCT02169934

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

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.

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Key information

Conditions

Age range

18 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Madison Clinical Research Unit

Madison, Wisconsin, 53704, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiolabeled TRV130

Drug

A single 2 mg IV dose administered as a 10 mL manual IV push over 2 minutes

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Trevena Inc.

Industry

Registry information

Official study title

A Study to Investigate the Metabolism and Excretion of [14C]-TRV130 Following Single Intravenous Dose Administration in Healthy Male Subjects

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 23, 2014
Registry last updated
Nov 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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