West China Hospital Si Chuan University
Chengdu, 610041, China
NCT Number: NCT04569695
The purpose of the study is to characterize the pharmacokinetics of single and multiple doses of JNJ-70033093 (BMS-986177) in healthy Chinese participants.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Chengdu, 610041, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
JNJ-70033093 capsule will be administered orally as per assigned treatment regimen.
Other names: BMS-986177
Time frame: Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B)
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)
Observed plasma concentration of JNJ-70033093 after multiple dose administration will be analyzed.
Time frame: Up to 54 Days
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 laboratories (such as Hematology, Coagulation, Serum chemistry and urinalysis) abnormalities will be assessed.
Time frame: Up to 54 Days
Number of participants with vital sign abnormalities (such as, blood pressure, pulse, respiratory rate, and temperature) will be assessed.
Time frame: Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B)
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)
Percentage change from baseline in FXI clotting activity will be measured using a modified aPTT assay.
Janssen Research & Development, LLC
Industry
A Phase 1, Randomized, Open-label, Parallel-group, Single- and Multiple-dose Study to Characterize Pharmacokinetics, Pharmacodynamics and Safety and Tolerability of JNJ-70033093 (BMS-986177) in Healthy Chinese Adult Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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