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

NCT04569695 | Completed Phase 1 FDA Drug

• 2 other identifiers: CR10880670033093THR1003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (5)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  Up to 54 Days

• Number of Participants with Clinical Laboratory Abnormalities

  Up to 54 Days

• Number of Participants with Vital Signs Abnormalities

  Up to 54 Days

• Change From Baseline in Activated Partial Thromboplastin Time (aPTT)

  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

  Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B)

Study Arms (4)

Part 1: Cohort A: JNJ-70033093

EXPERIMENTAL

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.

Drug: JNJ-70033093

Part 1: Cohort B: JNJ-70033093

EXPERIMENTAL

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

Drug: JNJ-70033093

Part 1: Cohort C: JNJ-70033093

EXPERIMENTAL

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

Drug: JNJ-70033093

Part 2: Cohort D: JNJ-70033093

EXPERIMENTAL

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.

Drug: JNJ-70033093

Interventions

JNJ-70033093 DRUG

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

Also known as: BMS-986177

Part 1: Cohort A: JNJ-70033093; Part 1: Cohort B: JNJ-70033093; Part 1: Cohort C: JNJ-70033093; Part 2: Cohort D: JNJ-70033093

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

West China Hospital Si Chuan University

Chengdu, 610041, China

Location

MeSH Terms

Interventions

milvexian

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 30, 2020
• Study Start: March 8, 2021
• Primary Completion: December 4, 2021
• Study Completion: December 16, 2021
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)