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Completed

NCT Number: NCT04569695

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

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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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

West China Hospital Si Chuan University

Chengdu, 610041, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-70033093

Drug

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

Other names: BMS-986177

Primary outcomes

  1. Cohort A and D: Plasma Concentration of JNJ-70033093 After Single Dose Administration

    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.

  2. Cohort A, B, C and D: Plasma Concentration of JNJ-70033093 After Multiple Dose Administration

    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.

Secondary outcomes

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

    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.

  2. Number of Participants with Clinical Laboratory Abnormalities

    Time frame: Up to 54 Days

    Number of participants with clinical laboratories (such as Hematology, Coagulation, Serum chemistry and urinalysis) abnormalities will be assessed.

  3. Number of Participants with Vital Signs Abnormalities

    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.

  4. Change From Baseline in Activated Partial Thromboplastin Time (aPTT)

    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).

  5. Percentage Change From Baseline in FXI Clotting Activity

    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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 30, 2020
Registry last updated
Mar 30, 2025

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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