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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005235-69 | EudraCT Number | ||
| 42847922MDD1012 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of JNJ-42847922 in adult participants with hepatic impairment when compared to healthy participants with normal hepatic function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Cohort 1 (JNJ-42847922) | Experimental | Participants with normal hepatic function will receive Dose 1 of JNJ-42847922 on Day 1. |
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| Part 1: Cohort 2 (JNJ-42847922) | Experimental | Participants with mild hepatic impairment will receive Dose 1 of JNJ-42847922 on Day 1. |
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| Part 1: Cohort 3 (JNJ-42847922) | Experimental | Participants with moderate hepatic impairment will receive Dose 2 of JNJ-42847922 on Day 1. |
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| Part 2: Cohort 4 (Optional) (JNJ-42847922) | Experimental | Participants with moderate hepatic impairment will receive Dose 1 (depending on the results of Cohort 3) of JNJ-42847922 on Day 1. |
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| Part 2: Cohort 5 (Optional) (JNJ-42847922) | Experimental | Participants with severe hepatic impairment will receive Dose 2 or Dose 3 (depending on the results of Part 1) of JNJ-42847922 on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-42847922 | Drug | Participants will receive JNJ-42847922 tablet as a single oral dose (Dose 1 or Dose 2 or Dose 3) on Day 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-42847922 and its Metabolites M12 and M16 | Cmax is defined as maximum observed plasma analyte concentration of JNJ-42847922 and its metabolites M12 and M16. | Pre-dose, up to 96 hours post-dose (up to Day 5) |
| Area Under Plasma Analyte Concentration versus Time Curve from Time Zero to Time of Last Measurable Concentration (AUC [0-last]) of JNJ-42847922 and its Metabolites M12 and M16 | AUC(0-last) is defined as area under the plasma analyte concentration versus time curve from time zero to time of last measurable concentration of JNJ-42847922 and its metabolites M12 and M16. | Pre-dose, up to 96 hours post-dose (up to Day 5) |
| Area Under the Plasma Analyte Concentration versus Time Curve from Time Zero to Infinite Time (AUC[0-Infinity]) of JNJ-42847922 and its Metabolites M12 and M16 | AUC(0-infinity) is defined as the area under the plasma analyte concentration versus time curve from time zero to infinite time of JNJ-42847922 and its metabolites M12 and M16. | Pre-dose, up to 96 hours post-dose (up to Day 5) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 Day 5 |
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Inclusion Criteria:
All
Exclusion Criteria:
Participants with normal hepatic function
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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 |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Kiel GmbH | Kiel | 24105 | Germany | |||
| APEX GmbH |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and 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 |
|---|---|
| C000655226 | seltorexant |
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| München |
| 81241 |
| Germany |