Healthy Volunteers
Conditions
Keywords
CC-99677, Healthy Male Participants, Pharmacokinetics, Absorption, Distribution, Metabolism, Excretion
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.
Interventions
DRUGCC-99677
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma AUC (total radioactivity (TRA))/Blood AUC (TRA) | Up to 15 days |
| Maximum plasma concentration of the drug (Cmax) for CC-99677 | Up to 15 days |
| Time of maximum observed plasma concentration (Tmax) 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 |
| Total radioactivity recovered in urine (UR) | Up to 15 days |
| Percent of total radioactivity recovered in urine (%UR) | Up to 15 days |
| Total radioactivity recovered in feces (FR) | Up to 15 days |
| Percent of total radioactivity recovered in feces (%FR) | Up to 15 days |
| Total radioactivity recovered in bile (BR) | Up to 15 days |
| Total radioactivity recovered in urine, feces, and bile combined (Rtotal) | Up to 15 days |
| Percent of total radioactivity recovered in all excreta (%Total) | Up to 15 days |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of serious adverse events (SAEs) | Up to 50 days |
| Incidence of AEs leading to discontinuation | Up to 15 days |
| Incidence of vital sign abnormalities | Up to 15 days |
| Incidence of electrocardiogram (ECG) abnormalities | Up to 15 days |
| Incidence of physical examination abnormalities | Up to 15 days |
| Incidence of clinical laboratory test abnormalities | Up to 15 days |
| Cmax | Up to 15 days |
| Tmax | Up to 15 days |
| AUC(0-T) | Up to 15 days |
| Incidence of adverse events (AEs) | Up to 50 days |
Countries
United States
Outcome results
None listed