Pharmacokinetics and Metabolism of [14C]BMS-986165 in Healthy Male Participants
Study Details
Study Description
Brief Summary
An oral dose in healthy subjects to obtain information about the absorption, metabolism, and excretion (AME) of BMS-986165
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single dose of radiolabeled BMS-986165
|
Drug: BMS-986165
Oral solution dose of 24 mg [14C] BMS-986165 containing approximately 100 micro Ci of TRA
|
Outcome Measures
Primary Outcome Measures
- The primary endpoint is PK exposure that will be determined from plasma concentration versus time [Day 1 to Day 13]
- Urinary/fecal TRA (Total radioactivity) recovery data [Day 1 to Day 13]
- PK terminal elimination half-life data (T-HALF) [Day 1 to Day 13]
- PK apparent total body clearance (CL/F) [Day 1 to Day 13]
- PK apparent volume of distribution (Vz/F) [Day 1 to Day 13]
- PK time of maximum observed plasma concentration (Tmax) [Day 1 to Day 13]
Secondary Outcome Measures
- Safety endpoints include the incidence of adverse events (AEs) [Day 1 to Day 13]
- Safety endpoints include the results of electrocardiogram tests (ECGs) [Day 1 to Day 13]
- Safety endpoints include the results of vital signs [Day 1 to Day 13]
- Safety endpoints include the results of physical exams [Day 1 to Day 13]
- Safety endpoints include the results of clinical laboratory tests [Day 1 to Day 13]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Signed Informed Consent
-
Target population: Healthy males with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests
-
Body weight of at least 50 kilograms (110 pounds); body mass index (BMI) between 18 to 32 kg/m2.
-
No evidence of acute infection or other significant problem as determined from a review of a chest x-ray, medical history, and physical examination
Exclusion Criteria:
-
History of any chronic or acute illness including active TB in the last 3 years, recent infection, gastrointestinal disease, smoking within less than 6 months prior to dosing, alcohol abuse, inability to tolerate oral medication, or inability to be venipunctured.
-
Vaccination or plans for vaccination with any live vaccine 12 weeks prior to first dose of study drug, during the course of the study
-
Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiograms, or clinical laboratory determinations beyond what is consistent with the target population.
-
Participant with greater than Grade 2 acne.
-
Participated in a radiolabeled drug study within the previous 12 months; clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months; or current employment in a job requiring radiation exposure monitoring.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Covance Madison Clinical Research Unit | Madison | Wisconsin | United States | 53704 |
Sponsors and Collaborators
- Bristol-Myers Squibb
- Covance
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- IM011-016