Psoriasis
Conditions
Brief summary
The purpose of this study is to evaluate sites of gut absorption of BMS-986165 in males
Interventions
DRUGBMS-986165
Oral administration
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Body mass index of 18.0 to 32.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening * Estimated glomerular filtration rate (eGFR) \> 80 mL/min/1.732 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula
Exclusion criteria
* Any significant acute or chronic medical illness * Current or recent (within 3 months of study drug administration) disease of the gut that, in the opinion of the Investigator or Medical Monitor, could impact upon the absorption of study drug * Acute diarrhea, or constipation within 3 weeks prior to randomization * Any major surgery within 4 weeks of randomization Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration (Cmax) of BMS-986165 following Treatments A, B, C, and D | Determined over 5 days |
| Time of maximum observed plasma concentration (Tmax) of BMS-986165 following Treatments A, B, C, and D | Determined over 5 days |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986165 following Treatments A, B, C, and D | Determined over 5 days |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986165 following Treatments A, B, C, and D | Determined over 5 days |
| Apparent plasma elimination half-life (T-HALF) of BMS-986165 following Treatments A, B, C, and D | Determined over 5 days |
Secondary
| Measure | Time frame |
|---|---|
| Vital sign of respiratory rate | Up to 60 days |
| Vital signs of body temperature | Up to 60 days |
| Vital sign of supine blood pressure | Up to 60 days |
| Pulse rate | Up to 60 days |
| Physical examination | Up to 60 days |
| Incidence of adverse events (AE) | Up to 90 days |
| Incidence of serious adverse events (SAE) | Up to 90 days |
Countries
United States
Outcome results
None listed