The purpose of the study is to evaluate the pharmacokinetics, safety and tolerability of BMS-708163 administered as single and multiple doses in Chinese subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
32
Capsule, Oral, 50 mg, once daily, 1 Day
Capsule, Oral, 125 mg, once daily, 14 Days
Capsule, Oral, 0 mg, One daily, 1 Day
West Coast Clinical Trials, Llc
Cypress, California, United States
California Clinical Trials Medical Group
Glendale, California, United States
Iberica Clinical Research Center
Eatontown, New Jersey, United States
Safety assessments will be based on adverse event reports and the results of vital sign measurements, ECGs, physical exams and clinical laboratory tests. Adverse events will be tabulated and reviewed for potential significance and clinical importance
Time frame: Study Day 1 through study completion + 30 days
Single-dose pharmacokinetic parameters (Cmax, Tmax, AUC(0-T), AUC(INF), T-HALF and multiple-dose pk parameters (Cmax, Tmax, Cmin, AUC(TAU), T-HALF, and accumulation index will be derived from plasma concentration versus time data
Time frame: Study Days 1-8 Period 1 and Days 1, 2, 5, 7, 9, 11, and 13-21 Period 2
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Capsule, Oral, 0 mg, One daily, 14 Day