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| ID | Type | Description | Link |
|---|---|---|---|
| 53718678RSV1010 | Other Identifier | Janssen Research & Development, LLC |
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A strategic decision was made to discontinue the study. The decision was not based on a safety concern.
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The main purpose of the study is to evaluate the pharmacokinetc (PK) of a single oral dose of JNJ-53718678 in participants with varying degrees of impaired hepatic function (mild, moderate, and severe) when compared with participants with normal hepatic function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Participants with Mild Hepatic Impairment | Experimental | Participants with mild hepatic impairment will receive a single oral dose of JNJ-53718678 suspension on Day 1. |
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| Group 2: Participants with Moderate Hepatic Impairment | Experimental | Participants with moderate hepatic impairment will receive a single oral dose of JNJ-53718678 suspension on Day 1. |
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| Group 3: Participants with Severe Hepatic Impairment | Experimental | Participants with severe hepatic impairment will receive a single oral dose of JNJ-53718678 suspension on Day 1. |
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| Group 4: Participants with Normal Hepatic Function | Experimental | Participants with normal hepatic function will receive a single oral dose of JNJ-53718678 suspension on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-53718678 | Drug | Participants will receive a single oral dose of JNJ-53718678 suspension on Day 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of JNJ-53718678 | Cmax is defined as the maximum plasma concentration of JNJ-53718678. | Predose, 15 minutes (min), 30 min, 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h and 96h postdose |
| Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUClast) of JNJ-53718678 | AUClast is defined as the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration of JNJ-53718678. | Predose, 15 min, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h and 96h postdose |
| Area Under the Plasma Concentration-time Curve From Time 0 to Infinite Time (AUC[0-infinity]) | AUC(0-infinity) is defined as the area under the plasma concentration-time curve from time 0 to infinite time calculated as the sum of AUClast and Clast/lz, in which Clast is the last observed quantifiable concentration. | Predose, 15 min, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h and 96h postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. | From screening up to Day 14 (Up to 42 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States | ||
| The Texas Liver Institute |
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 |
|---|---|
| C000624632 | JNJ-53718678 |
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| San Antonio |
| Texas |
| 78215 |
| United States |