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| ID | Type | Description | Link |
|---|---|---|---|
| 75105186CRD1001 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
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Business Decision
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The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of JNJ-75105186 after single ascending oral dose administration in healthy Japanese participants and after single oral dose administration in healthy Chinese participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Single Ascending Dose (SAD) Cohorts | Experimental | Healthy Japanese participants will receive JNJ-75105186 or matching placebo orally in Cohorts 1-3. |
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| Part 2: Single Dose (SD) Cohort | Experimental | Healthy Chinese participants will receive JNJ-75105186 or matching placebo orally in Cohort 4. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-75105186 | Drug | JNJ-75105186 will be administered orally in Part 1 and 2. |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1 and 2: Number of Participants with Adverse Events 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 |
| Part 1 and 2: Plasma Concentration of JNJ-75105186 | Plasma samples will be analyzed to determine concentrations of JNJ-75105186 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 Fukuoka Mirai Hospital | Fukuoka | 813-0017 | 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 | Other | Matching placebo to JNJ-75105186 will be administered orally in Parts 1 and 2. |
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