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| ID | Type | Description | Link |
|---|---|---|---|
| 77242113PSO1002 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
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The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of JNJ-77242113 after single ascending oral dose administration as an immediate-release (IR) tablet formulation in healthy Japanese participants and after single oral dose administration as an IR tablet formulation in healthy Chinese participants; and as a delayed release (DR) tablet formulation in healthy Japanese participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: JNJ-77242113 or Placebo (Single Ascending Dose [SAD]) | Experimental | Japanese participants will receive single oral dose 1 of JNJ-77242113 (immediate-release [IR] tablet) or matching placebo on Day 1 in Cohort 1 of Part 1. |
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| Cohort 2: JNJ-77242113 or Placebo (SAD) | Experimental | Japanese participants will receive single oral dose 2 of JNJ-77242113 (IR tablet) or matching placebo on Day 1 in Cohort 2 of Part 1. |
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| Cohort 3: JNJ-77242113 or Placebo (Single Dose [SD]) | Experimental | Chinese participants will receive single oral dose 2 of JNJ-77242113 (IR tablet) or matching placebo on Day 1 in Cohort 3 of Part 2. |
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| Cohort 4: JNJ-77242113 or Placebo (SD) | Experimental | Japanese participants will receive single oral dose 3 of JNJ-77242113 (delayed-release [DR] tablet) with absorption enhancer (AbE) or matching placebo on Day 1 in Cohort 4 of Part 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-77242113 | Drug | JNJ-77242113 will be administered as an oral tablet. |
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| Measure | Description | Time Frame |
|---|---|---|
| Parts 1, 2 and 3: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. | Up to 6 weeks |
| Parts 1, 2 and 3: Plasma Concentration of JNJ-77242113 | Plasma samples will be analyzed to determine concentrations of JNJ-77242113 using a validated, specific and sensitive method. | Predose up to 48 hours postdose (Up to Day 3) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Souseikai Hakata Clinic | Fukuoka | 812-0025 | Japan |
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
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| Placebo | Drug | Matching placebo will be administered as an oral tablet. |
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