A Study to Evaluate the Drug Levels of [14C]CC-99677 in Healthy Male Participants
- Registration Number
- NCT05284890
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of the study is to characterize the absorption, distribution, metabolism and excretion (ADME) of a single oral dose of \[14C\] CC-99677.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 8
Inclusion Criteria
- Healthy male participants
- Body mass index of 18.0 to 33.0 kg/m^2, inclusive
Exclusion Criteria
- Any significant acute or chronic medical illness
- Any major surgery within 4 weeks of intervention administration
- History of any significant drug allergy
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CC-99677 CC-99677 -
- Primary Outcome Measures
Name Time Method Maximum plasma concentration of the drug (Cmax) for CC-99677 Up to 15 days Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) for CC-99677 Up to 15 days Percent of total radioactivity recovered in urine (%UR) Up to 15 days Percent of total radioactivity recovered in feces (%FR) Up to 15 days Percent of total radioactivity recovered in all excreta (%Total) Up to 15 days Plasma AUC (total radioactivity (TRA))/Blood AUC (TRA) Up to 15 days Total radioactivity recovered in urine (UR) Up to 15 days Total radioactivity recovered in feces (FR) Up to 15 days Total radioactivity recovered in bile (BR) Up to 15 days Time of maximum observed plasma concentration (Tmax) for CC-99677 Up to 15 days Total radioactivity recovered in urine, feces, and bile combined (Rtotal) Up to 15 days
- Secondary Outcome Measures
Name Time Method Incidence of adverse events (AEs) Up to 50 days Incidence of physical examination abnormalities Up to 15 days AUC(0-T) Up to 15 days Incidence of AEs leading to discontinuation Up to 15 days Cmax Up to 15 days Incidence of vital sign abnormalities Up to 15 days Incidence of electrocardiogram (ECG) abnormalities Up to 15 days Tmax Up to 15 days Incidence of serious adverse events (SAEs) Up to 50 days Incidence of clinical laboratory test abnormalities Up to 15 days
Trial Locations
- Locations (1)
Local Institution - 0001
🇺🇸Madison, Wisconsin, United States