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

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT04569695
Collaborator
(none)
40
Enrollment
1
Location
4
Arms
9.3
Actual Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Actual Study Start Date :
Mar 8, 2021
Actual Primary Completion Date :
Dec 4, 2021
Actual Study Completion Date :
Dec 16, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: JNJ-70033093
JNJ-70033093 capsule will be administered orally as per assigned treatment regimen.
Other Names:
  • BMS-986177

    		•
    Experimental: Part 1: Cohort B: JNJ-70033093

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

    Drug: JNJ-70033093
    JNJ-70033093 capsule will be administered orally as per assigned treatment regimen.
    Other Names:
  • BMS-986177

    		•
    Experimental: Part 1: Cohort C: JNJ-70033093

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

    Drug: JNJ-70033093
    JNJ-70033093 capsule will be administered orally as per assigned treatment regimen.
    Other Names:
  • BMS-986177

    		•
    Experimental: 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.

    Drug: JNJ-70033093
    JNJ-70033093 capsule will be administered orally as per assigned treatment regimen.
    Other Names:
  • BMS-986177

    		•

    Outcome Measures

    Primary Outcome Measures

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

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 West China Hospital, Si Chuan University Chengdu China 610041

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

    • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT04569695
    Other Study ID Numbers:
    • CR108806
    • 70033093THR1003
    First Posted:
    Sep 30, 2020
    Last Update Posted:
    Feb 2, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes

    Study Results

    No Results Posted as of Feb 2, 2022