Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986278 in Healthy Male Participants
- Registration Number
- NCT04567667
- 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-986278 as well as the safety and tolerability of BMS-986278 in healthy male participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 9
Inclusion Criteria
- No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), vital signs, and clinical laboratory determinations
- Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, and total body weight ≥50 kg (110 lb), at screening. BMI = weight (kg)/(height [m])2
- Males must agree to follow specific methods of contraception, if applicable
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, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
- Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could impact upon the absorption of study treatment
- Any major surgery within 6 weeks of study treatment administration
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2 Kinevac® - Group 1 [14C] BMS-986278 - Group 2 [14C] BMS-986278 -
- Primary Outcome Measures
Name Time Method Maximum observed plasma concentration (Cmax) of BMS-986278 Up to 15 days Maximum observed plasma concentration (Cmax) of total radioactivity (TRA) Up to 15 days Time of maximum observed plasma concentration (Tmax) of BMS-986278 Up to 15 days Time of maximum observed plasma concentration (Tmax) of TRA Up to 15 days Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) of BMS-986278 Up to 15 days Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) of TRA Up to 15 days
- Secondary Outcome Measures
Name Time Method Incidence of clinically significant changes in vital signs: Respiratory rate Up to 43 days Incidence of clinically significant changes in physical examination findings Up to 43 days Incidence of clinically significant changes in clinical laboratory results: Hematology tests Up to 43 days Incidence of Serious Adverse Events (AEs) Up to 73 days Incidence of clinically significant changes in vital signs: Heart rate Up to 43 days Incidence of Adverse Events (AEs) Up to 15 days Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests Up to 43 days Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests Up to 43 days Incidence of clinically significant changes in vital signs: Blood pressure Up to 43 days Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF Up to 43 days QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave.
Incidence of clinically significant changes in vital signs: Body temperature Up to 43 days Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval Up to 43 days The QT interval is the time from the start of the Q wave to the end of the T wave.
Trial Locations
- Locations (1)
Covance - Clinical Pharmacology Services - Madison
🇺🇸Madison, Wisconsin, United States