A Study of JNJ-70033093 (BMS-986177) in Healthy Chinese Adult Participants

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04569695
• Other study ID #: CR108806
• Secondary ID: 70033093THR1003
• Status: Completed
• Phase: Phase 1
• Start date: March 8, 2021
• Est. completion date: December 16, 2021

Study information

• Verified date: December 2023
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 16, 2021
• Est. primary completion date: December 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• JNJ-70033093
JNJ-70033093 capsule will be administered orally as per assigned treatment regimen.

Locations

Country	Name	City	State
China	West China Hospital, Si Chuan University	Chengdu

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B)
Primary	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.	Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B)
Secondary	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.	Up to 54 Days
Secondary	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.	Up to 54 Days
Secondary	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.	Up to 54 Days
Secondary	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).	Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B)
Secondary	Percentage Change From Baseline in FXI Clotting Activity	Percentage change from baseline in FXI clotting activity will be measured using a modified aPTT assay.	Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B)