Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986256 in Healthy Male Participants
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Detailed Description
Recruitment temporarily on hold due to COVID-19.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: BMS-986256
|
Drug: BMS-986256
Specified dose on specified days
Drug: Milk of magnesia
Specified dose on specified days
|
Outcome Measures
Primary Outcome Measures
- Maximum observed plasma concentration (Cmax) of [14C] BMS-986256 [Up to 49 days]
- Time to attain maximum observed plasma concentration (Tmax) 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]
Secondary Outcome Measures
- Incidence of Adverse Events (AEs) [Up to 49 days]
- Incidence of Serious Adverse Events (SAEs) [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 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: Blood pressure [Up to 49 days]
- Incidence of clinically significant changes in vital signs: Heart rate [Up to 49 days]
- Incidence of clinically significant changes in vital signs: Respiratory rate [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]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Covance - Clinical Pharmacology Services - Madison | Madison | Wisconsin | United States | 53704 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- BMS Clinical Trial Information
- BMS Clinical Trial Patient Recruiting
- Investigator Inquiry Form
- FDA Safety Alerts and Recalls
Publications
None provided.- IM026-023