Pharmacokinetics and Metabolism Study of Radiolabeled BMS-986142 in Healthy Male Subjects

November 15, 2016 updated by: Bristol-Myers Squibb

Pharmacokinetics and Metabolism of [14C] BMS-986142 in Healthy Male Subjects

This is an open-label, single-dose, study in healthy males. The primary objective is to assess the pharmacokinetics (PK), metabolism, and routes of elimination of a single oral dose of radiolabeled BMS-986142 in healthy male subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53704
        • Covance Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Signed Informed Consent
  • Target population: Healthy males with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests
  • Body weight of at least 50 kilograms (110 pounds); body mass index (BMI) between 18 to 32 kg/m2.

Exclusion Criteria:

  • History of any chronic or acute illness including active TB in the last 3 years, recent infection, gastrointestinal disease, smoking within less than 6 months prior to dosing, alcohol abuse, inability to tolerate oral medication, or inability to be venipunctured.
  • Vaccination or plans for vaccination with any live vaccine 12 weeks prior to first dose of study drug, during the course of the study, or 30 days after the last dose of study drug.
  • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiograms, or clinical laboratory determinations beyond what is consistent with the target population.
  • History of allergies and adverse drug reaction to any oral contraceptive compounds or Bruton tyrosine kinase (BTK) inhibitors.
  • Participated in a radiolabeled drug study within the previous 12 months; clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months; or current employment in a job requiring radiation exposure monitoring.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single dose of radiolabeled BMS-986142
Drug: BMS-986142

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary endpoint is PK parameters that will be determined from plasma concentration versus time
Time Frame: Day 1 to Day 13
Day 1 to Day 13
Urinary/fecal/bile (if applicable) TRA (Total radioactivity) recovery data
Time Frame: Day 1 to Day 13
Day 1 to Day 13

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and the results of electrocardiogram tests (ECGs), vital signs, physical exams, and clinical laboratory tests.
Time Frame: Day 1 to Day 13
Day 1 to Day 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

August 15, 2016

First Submitted That Met QC Criteria

August 23, 2016

First Posted (Estimate)

August 26, 2016

Study Record Updates

Last Update Posted (Estimate)

November 16, 2016

Last Update Submitted That Met QC Criteria

November 15, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM006-022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arthritis

Clinical Trials on BMS-986142

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe