Clinical trial NCT04569695: A Study of JNJ-70033093 (BMS-986177) in Healthy Chinese Adult Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2020-09-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the study is to characterize the pharmacokinetics of single and multiple doses of JNJ-70033093 (BMS-986177) in healthy Chinese participants.


Eligibility criteria: Inclusion criteria:

* Healthy on the basis of physical examination, medical history, vital signs, Electrocardiogram (ECG), and the results of serum biochemistry, blood coagulation and hematology test and a urinalysis performed at screening. If there are abnormalities, investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the subject's source documents and initialed by the investigator
* Must sign an Informed consent Form (ICF) indicating that they understand the purpose of, and procedures required for the study and is willing to participate in the study
* If a woman, except for postmenopausal women, must have a negative highly sensitive serum (beta human chorionic gonadotropin \[beta hCG\]) at screening and urine (beta-hCG) pregnancy test on Day -1
* Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for subject participating in clinical studies
* Before randomization, a woman must be either not of childbearing potential; of childbearing potential and practicing a highly effective method of contraception and agrees to remain on a highly effective method throughout the study and for at least 34 days after the last dose of study drug; women must have no history of excessive menstrual bleeding or hemorrhage following pregnancy delivery

Exclusion criteria:

* If a woman, pregnant, breast-feeding or planning to become pregnant during the study
* Participants with current hepatitis B infection (confirmed by hepatitis B surface antigen \[HBsAg\]), or hepatitis C infection (confirmed by hepatitis C virus \[HCV\] antibody), or human immunodeficiency virus type-1 (HIV-1) or HIV-2 infection at study screening
* History of, or a reason to believe a subject has a history of, drug or alcohol abuse within the past 1 year, which in the Investigator's opinion would compromise subject's safety and/or compliance with the study procedures
* History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) and known allergy to the study drug or any of the excipients of the formulation
* Preplanned surgery or procedures that would interfere with the conduct of the study

Primary outcomes:
measure: Cohort A and D: Plasma Concentration of JNJ-70033093 After Single Dose Administration
timeFrame: Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B)
measure: Cohort A, B, C and D: Plasma Concentration of JNJ-70033093 After Multiple Dose Administration
timeFrame: Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B)
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to 54 Days
measure: Number of Participants with Clinical Laboratory Abnormalities
timeFrame: Up to 54 Days
measure: Number of Participants with Vital Signs Abnormalities
timeFrame: Up to 54 Days
measure: Change From Baseline in Activated Partial Thromboplastin Time (aPTT)
timeFrame: Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B)
measure: Percentage Change From Baseline in FXI Clotting Activity
timeFrame: Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B)
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital Si Chuan University
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: