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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-003071-20 | EudraCT Number | ||
| 56136379HPB1009 | Other Identifier | Janssen Sciences Ireland UC |
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The purpose of the study is to evaluate the pharmacokinetics (PK) of a single oral dose of JNJ-56136379 in participants with liver cirrhosis and impaired hepatic function when compared with healthy participants with normal hepatic function and no liver cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Group 1 | Experimental | Participants with liver cirrhosis with moderate hepatic impairment will receive a single oral dose of JNJ-56136379 in fed condition. |
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| Part A: Group 2 | Experimental | Participants with normal liver function with no liver cirrhosis will receive a single oral dose of JNJ-56136379 in fed condition. |
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| Part B: Group 3 (optional) | Experimental | Participants with liver cirrhosis with mild hepatic impairment will receive a single oral dose of JNJ-56136379 in fed condition. |
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| Part B: Group 4 (optional) | Experimental | Participants with liver cirrhosis with severe hepatic impairment will receive a single oral dose of JNJ-56136379 in fed condition. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-56136379 | Drug | JNJ-56136379 will be administered orally in fed condition. |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of JNJ-56136379 | Plasma concentration of oral dose of JNJ-56136379 will be assessed. | Up to Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | Up to 6 months |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Sciences Ireland UC Clinical Trials | Janssen Sciences Ireland UC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| APEX GmbH | München | 81241 | Germany |
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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| ID | Term |
|---|---|
| C000716080 | JNJ-56136379 |
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