A Phase 1, Single-center, Open-label Study to Evaluate the Metabolism and Excretion of [14C]CC-99677 in Healthy Male Participants
Overview
- Phase
- Phase 1
- Intervention
- CC-99677
- Conditions
- Healthy Volunteers
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Total radioactivity recovered in feces (FR)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
CC-99677
Intervention: CC-99677
Outcomes
Primary Outcomes
Total radioactivity recovered in feces (FR)
Time Frame: Up to 15 days
Maximum plasma concentration of the drug (Cmax) for CC-99677
Time Frame: 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
Time Frame: Up to 15 days
Percent of total radioactivity recovered in urine (%UR)
Time Frame: Up to 15 days
Percent of total radioactivity recovered in feces (%FR)
Time Frame: Up to 15 days
Percent of total radioactivity recovered in all excreta (%Total)
Time Frame: Up to 15 days
Plasma AUC (total radioactivity (TRA))/Blood AUC (TRA)
Time Frame: Up to 15 days
Total radioactivity recovered in urine (UR)
Time Frame: Up to 15 days
Total radioactivity recovered in bile (BR)
Time Frame: Up to 15 days
Time of maximum observed plasma concentration (Tmax) for CC-99677
Time Frame: Up to 15 days
Total radioactivity recovered in urine, feces, and bile combined (Rtotal)
Time Frame: Up to 15 days
Secondary Outcomes
- Incidence of serious adverse events (SAEs)(Up to 50 days)
- Incidence of clinical laboratory test abnormalities(Up to 15 days)
- 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)