The purpose of this study is to investigate the effect of a light meal and a high-fat meal on the bioavailability (absorption) of of BMS-986205 commercial tablet in healthy participants. Eligible participants will receive a single dose of BMS-986205 under fasted or fed (high-fat meal or light meal) conditions on Day 1 and Day 15. The safety, tolerability and movement of the BMS-986205 into, through and out of the body (pharmacokinetics/PK) under these conditions will be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
32
Single dose, 100 mg administered at Day 1 and at Day 15.
PPD Austin Clinic
Austin, Texas, United States
Maximum observed plasma concentration (Cmax) following administration of single, 100 mg tablet of BMS-986205 with a high-fat meal.
Measured by plasma concentration.
Time frame: Up to 21 days
Area under the plasma concentration-time curve from time zero to 168 hours (AUC[0-168]) following administration of single, 100 mg tablet of BMS-986205 with a high-fat meal.
Measured by plasma concentration.
Time frame: Up to 21 days
Cmax following administration of single, 100 mg tablet of BMS-986205 with a light meal.
Measured by plasma concentration.
Time frame: Up to 21 days
AUC(0-168) following administration of single, 100 mg tablet of BMS-986205 with a light meal.
Measured by plasma concentration.
Time frame: Up to 21 days
Number of participants with non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) following administration of single, 100 mg tablet of BMS-986205 under fasting conditions, with a light meal or with a high-fat meal.
Safety and tolerability of BMS-986205 measured by investigator assessment.
Time frame: Day 1 up to Day 22
Results of clinical laboratory tests
Measured by Investigator assessment
Time frame: Up to 22 days
Results of vital sign measurements
Measured by Investigator assessment
Time frame: Up to 22 days
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Results of electrocardiogram (ECG)
Measured by Investigator Assessment
Time frame: Up to 22 days