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
- Overall Contact(s)
- Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,, please email:, Clinical.Trials@bms.com
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