Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 70033093THR1003 | Other Identifier | Janssen Research & Development, LLC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to characterize the pharmacokinetics of single and multiple doses of JNJ-70033093 (BMS-986177) in healthy Chinese participants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Part 1: Cohort B: JNJ-70033093 | Experimental | Participants will receive Dose 1 of JNJ-70033093 twice daily (BID) from Days 1 to 8. |
|
| Part 1: Cohort C: JNJ-70033093 | Experimental | Participants will receive Dose 2 of JNJ-70033093 BID from Days 1 to 8. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-70033093 | Drug | JNJ-70033093 capsule will be administered orally as per assigned treatment regimen. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Number of participants who experience at least 1 occurrence of each treatment emergent adverse event (TEAE) will be assessed. | Up to 54 Days |
| Number of Participants with Clinical Laboratory Abnormalities |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital Si Chuan University | Chengdu | 610041 | China |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000720754 | milvexian |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Number of participants with clinical laboratories (such as Hematology, Coagulation, Serum chemistry and urinalysis) abnormalities will be assessed. |
| Up to 54 Days |
| Number of Participants with Vital Signs Abnormalities | Number of participants with vital sign abnormalities (such as, blood pressure, pulse, respiratory rate, and temperature) will be assessed. | Up to 54 Days |
| Change From Baseline in Activated Partial Thromboplastin Time (aPTT) | 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). | 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 | Percentage change from baseline in FXI clotting activity will be measured using a modified aPTT assay. | Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B) |