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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: JNJ-70033093

• Registration Number: NCT04569695
• Lead Sponsor: Janssen Research & Development, LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-11
• Study First Submitted QC: 2020-09-29
• Study First Posted: 2020-09-30
• Study Start: 2021-03-08
• Primary Completion: 2021-12-04
• Study Completion: 2021-12-16
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-22
• Last Update Posted: 2023-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 1: Cohort A: JNJ-70033093	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.
Part 1: Cohort B: JNJ-70033093	JNJ-70033093	Participants will receive Dose 1 of JNJ-70033093 twice daily (BID) from Days 1 to 8.
Part 1: Cohort C: JNJ-70033093	JNJ-70033093	Participants will receive Dose 2 of JNJ-70033093 BID from Days 1 to 8.
Part 2: Cohort D: JNJ-70033093	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.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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).

Trial Locations

Locations (1)

West China Hospital, Si Chuan University; 🇨🇳 Chengdu, China