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

NCT ID: NCT04569695

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-08
• Study Completion Date: 2021-12-16

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Part 1: Cohort A: JNJ-70033093

Participants will receive Dose 1 of JNJ-70033093 once daily (QD) on Day 1 followed by washout period of 4 days and then Dose 1 of JNJ-70033093 QD from Days 5 to 12.

Group Type: EXPERIMENTAL

JNJ-70033093

Intervention Type: DRUG

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

Part 1: Cohort B: JNJ-70033093

Participants will receive Dose 1 of JNJ-70033093 twice daily (BID) from Days 1 to 8.

Group Type: EXPERIMENTAL

JNJ-70033093

Intervention Type: DRUG

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

Part 1: Cohort C: JNJ-70033093

Participants will receive Dose 2 of JNJ-70033093 BID from Days 1 to 8.

Group Type: EXPERIMENTAL

JNJ-70033093

Intervention Type: DRUG

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

Part 2: Cohort D: JNJ-70033093

Participants will receive Dose 3 of JNJ-70033093 QD on Day 1 followed by washout period of 4 days and then Dose 3 of JNJ-70033093 BID from Days 5 to 12 in Cohort D. Dose escalation to Part 2: Cohort D will occur only after the safety and tolerability data of the Part 1 are assessed.

Group Type: EXPERIMENTAL

JNJ-70033093

Intervention Type: DRUG

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

Interventions

JNJ-70033093

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

Intervention Type: DRUG

Other Intervention Names

BMS-986177

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

West China Hospital Si Chuan University

Chengdu, , China

Countries

China

Other Identifiers

70033093THR1003

Identifier Type: OTHER

Identifier Source: secondary_id

CR108806

Identifier Type: -

Identifier Source: org_study_id