A Study to Evaluate the Drug Levels of BMS-986166 in Healthy Male Participants

March 20, 2023 updated by: Bristol-Myers Squibb

A Phase 1, Single-center, Open-label Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of [14C] BMS-986166 in Healthy Male Participants

The purpose of this study is to assess the drug levels of BMS-986166 in healthy male participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

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, 53704-2526
        • Local Institution - 0001

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 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations
  • Body mass index between 18.0 to 33.0 kg/m2 (inclusive)

Exclusion Criteria:

  • Any significant acute or chronic medical illness
  • Current or recent history of constipation or irregular bowel movement (less than 1 bowel movement per day within the last 1 week)
  • History of allergy (such as rash, hives, breathing difficulties) to any medications, either prescription or nonprescription

Other protocol-defined inclusion/exclusion criteria apply

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group 1: BMS-986166
Drug: BMS-986166
Specified dose on specified days
Drug: Bisacodyl
Specified dose on specified days
Other Names:
  • Dulcolax®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total amount of total radioactivity (TRA) recovered in urine (UR)
Time Frame: Up to 90 days
Up to 90 days
Total amount of TRA recovered in feces (FR)
Time Frame: Up to 90 days
Up to 90 days
Total amount of TRA recovered in urine and feces combined (RTotal)
Time Frame: Up to 90 days
Up to 90 days
Percent of TRA recovered in urine (%UR)
Time Frame: Up to 90 days
Up to 90 days
Percent of TRA recovered in feces (%FR)
Time Frame: Up to 90 days
Up to 90 days
Percent of TRA recovered in urine and feces combined (%TOTAL)
Time Frame: Up to 90 days
Up to 90 days
Maximum observed concentration (Cmax)
Time Frame: Up to 89 days
Up to 89 days
Time of maximum observed concentration (Tmax)
Time Frame: Up to 89 days
Up to 89 days
Area under the concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]
Time Frame: Up to 89 days
Up to 89 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum observed concentration (Cmax)
Time Frame: Up to 89 days
Up to 89 days
Time of maximum observed concentration (Tmax)
Time Frame: Up to 89 days
Up to 89 days
Area under the concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]
Time Frame: Up to 89 days
Up to 89 days
Number of participants with adverse events (AEs)
Time Frame: Up to 124 days
Up to 124 days
Number of participants with serious adverse events (SAEs)
Time Frame: Up to 124 days
Up to 124 days
Number of participants with vital sign abnormalities
Time Frame: Up to 90 days
Up to 90 days
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame: Up to 90 days
Up to 90 days
Number of participants with physical examination abnormalities
Time Frame: Up to 90 days
Up to 90 days
Number of participants with clinical laboratory test abnormalities
Time Frame: Up to 90 days
Up to 90 days

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 (Actual)

June 17, 2022

Primary Completion (Actual)

October 15, 2022

Study Completion (Actual)

October 15, 2022

Study Registration Dates

First Submitted

June 3, 2022

First Submitted That Met QC Criteria

June 3, 2022

First Posted (Actual)

June 8, 2022

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 20, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM018-010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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.

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