Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986278 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-986278 as well as the safety and tolerability of BMS-986278 in healthy male participants.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Group 1
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Drug: [14C] BMS-986278
Specified dose on specified days
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Experimental: Group 2
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Drug: [14C] BMS-986278
Specified dose on specified days
Drug: Kinevac®
Specified dose on specified days
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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
- Incidence of Adverse Events (AEs) [Up to 15 days]
- Incidence of Serious Adverse Events (AEs) [Up to 73 days]
- Incidence of clinically significant changes in clinical laboratory results: Hematology tests [Up to 43 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 vital signs: Heart rate [Up to 43 days]
- Incidence of clinically significant changes in vital signs: Respiratory rate [Up to 43 days]
- Incidence of clinically significant changes in vital signs: Body temperature [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 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.
- Incidence of clinically significant changes in physical examination findings [Up to 43 days]
Eligibility Criteria
Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
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No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), vital signs, and clinical laboratory determinations
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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
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Males must agree to follow specific methods of contraception, if applicable
Exclusion Criteria:
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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
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Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could impact upon the absorption of study treatment
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Any major surgery within 6 weeks of study treatment administration
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.- IM027-048