Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986256 in Healthy Male Participants

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: BMS-986256; Drug: Milk of magnesia

• Registration Number: NCT04269356
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to assess the way the body absorbs, distributes, breaks down and eliminates radioactive BMS-986856 in healthy males.

Detailed Description

Recruitment temporarily on hold due to COVID-19.

Study Timeline

• Study First Submitted: 2020-02-12
• Study First Submitted QC: 2020-02-12
• Study First Posted: 2020-02-13
• Study Start: 2020-02-18
• Primary Completion: 2021-03-30
• Study Completion: 2021-03-30
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-19
• Last Update Posted: 2022-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

• Healthy participants, as determined by no clinically significant deviations from normal in medical history, physical examination abnormalities that would compromise the ability to participate, complete, and/or interpret the results of the study, 12-lead electrocardiograms (ECGs), vital signs, and clinical laboratory results.
• Males must agree to follow specific methods of contraception, if applicable, while participating in the trial

Exclusion Criteria

• Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study
• History of any significant drug and/or food allergies

Other protocol-defined inclusion/exclusion criteria apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BMS-986256	BMS-986256	-
BMS-986256	Milk of magnesia	-

Primary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax) of [14C] BMS-986256	Up to 49 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC (0-T)) of [14C] BMS-986256	Up to 49 days
Time to attain maximum observed plasma concentration (Tmax) of [14C] BMS-986256	Up to 49 days

Secondary Outcome Measures

Name	Time	Method
Incidence of clinically significant changes in vital signs: Heart rate	Up to 49 days
Incidence of Serious Adverse Events (SAEs)	Up to 49 days
Incidence of clinically significant changes in vital signs: Blood pressure	Up to 49 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests	Up to 49 days
Incidence of clinically significant changes in vital signs: Respiratory rate	Up to 49 days
Incidence of Adverse Events (AEs)	Up to 49 days
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests	Up to 49 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests	Up to 49 days
Incidence of clinically significant changes in vital signs: Body temperature	Up to 49 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters	Up to 49 days
Incidence of clinically significant changes in physical examination findings	Up to 49 days

Trial Locations

Locations (1)

Covance - Clinical Pharmacology Services - Madison; 🇺🇸 Madison, Wisconsin, United States