The purpose of the study is to characterize the pharmacokinetics of single and multiple doses of JNJ-70033093 (BMS-986177) in healthy Chinese participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
40
JNJ-70033093 capsule will be administered orally as per assigned treatment regimen.
West China Hospital Si Chuan University
Chengdu, China
Cohort A and D: Plasma Concentration of JNJ-70033093 After Single Dose Administration
Plasma concentration of JNJ-70033093 after single dose administration will be analyzed.
Time frame: Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B)
Cohort A, B, C and D: Plasma Concentration of JNJ-70033093 After Multiple Dose Administration
Observed plasma concentration of JNJ-70033093 after multiple dose administration will be analyzed.
Time frame: Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Number of participants who experience at least 1 occurrence of each treatment emergent adverse event (TEAE) will be assessed.
Time frame: Up to 54 Days
Number of Participants with Clinical Laboratory Abnormalities
Number of participants with clinical laboratories (such as Hematology, Coagulation, Serum chemistry and urinalysis) abnormalities will be assessed.
Time frame: Up to 54 Days
Number of Participants with Vital Signs Abnormalities
Number of participants with vital sign abnormalities (such as, blood pressure, pulse, respiratory rate, and temperature) will be assessed.
Time frame: Up to 54 Days
Change From Baseline in Activated Partial Thromboplastin Time (aPTT)
Activated partial thromboplastin time measures the time to clot formation via the intrinsic (contact) and common pathways, and is dependent on activation of contact factors (such as FXI).
Time frame: Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B)
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Percentage Change From Baseline in FXI Clotting Activity
Percentage change from baseline in FXI clotting activity will be measured using a modified aPTT assay.
Time frame: Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B)