Healthy Participants
Conditions
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.
Interventions
DRUGBMS-986256
Specified dose on specified days
DRUGMilk of magnesia
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 Adverse Events (AEs) | 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 |
| Incidence of clinically significant changes in vital signs: Respiratory rate | 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 |
Countries
United States
Outcome results
None listed