Psoriasis
Conditions
Brief summary
This is an investigational study of Cyclosporine on the experimental medication BMS-986165 in healthy male participants.
Interventions
DRUGBMS-986165
Specified dose on specified days
DRUGCyclosporine
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations * Body mass index 18.0 to 32.0 kg/m2 * Weight ≥ 50 kg
Exclusion criteria
* Any medical condition that presents a potential risk to the subject and/or may compromise the objectives of the study, including a history of or active liver disease * History or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening * Known or suspected autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status * History of administration of live vaccines within 60 days before screening * Any history or risk for tuberculosis (TB) Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum concentration (Cmax) | 24 hours |
| Area under the concentration vs time curve from time zero to 24 hours post dose (AUC[0-24]) | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events (AEs) | Up to 20 days |
Countries
United States
Outcome results
None listed