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

Overview

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

Full Title of Study: “Pharmacokinetics and Metabolism of a Single Dose of [14C] BMS-986256 in Healthy Male Participants”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: October 6, 2020

Detailed Description

Recruitment temporarily on hold due to COVID-19.

Interventions

• Drug: BMS-986256
  • Specified dose on specified days
• Drug: Milk of magnesia
  • Specified dose on specified days

Arms, Groups and Cohorts

• Experimental: BMS-986256

Clinical Trial Outcome Measures

Primary Measures

• Maximum observed plasma concentration (Cmax) of [14C] BMS-986256
  • Time Frame: Up to 49 days
• Time to attain maximum observed plasma concentration (Tmax) of [14C] BMS-986256
  • Time Frame: 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
  • Time Frame: Up to 49 days

Secondary Measures

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

Participating in This Clinical Trial

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Bristol-Myers Squibb
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb