A Study to Evaluate the Effect of Hepatic Impairment on JNJ-42847922 in Adult Participants

Study Overview
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Brief Summary
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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.

Official Title
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An Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of JNJ-42847922 in Adult Participants

Conditions
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Healthy, Hepatic Impairment

Intervention / Treatment
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* Drug: JNJ-42847922


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All Be a man or woman 18 to 79 years of age, inclusive Participants with normal hepatic function Generally healthy Must not exceed upper limit of normal limits for serum bilirubin, transaminase levels, albumin levels, prothrombin time (PT), and International Normalized Ratio (INR) when measured at screening and Day 1 Participants with (Mild, Moderate or Severe) hepatic impairment Medically stable Total Child-Pugh score of 5 or 6, inclusive (mild); or 7 to 9, inclusive (moderate); or 10 to 15, inclusive (severe) as determined by the investigator Stable hepatic function during screening and those measured on Day 1 Stable renal function Exclusion Criteria: Participants with normal hepatic function Hepatitis B surface antigen (HBsAg) or hepatitis C antibodies at screening Participants with (Mild, Moderate or Severe) hepatic impairment Severe ascites or pleural effusion; prothrombin time greater than (>)18 seconds; evidence of progressive liver disease within the previous 4 weeks, as indicated by changes in hepatic transaminases, alkaline phosphatase, and gamma-glutamyl transferase History of hepatopulmonary syndrome, hydrothorax, or significant hepatorenal syndrome Acute or exacerbating hepatitis, fluctuating or rapidly deteriorating hepatic function as indicated by widely varying or worsening of clinical and/or laboratory signs of hepatic impairment in the judgment of either the investigator or the sponsor's medical monitor Clinically significant laboratory findings except as related to hepatic impairment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: Cohort 1 (JNJ-42847922)<br>Participants with normal hepatic function will receive Dose 1 of JNJ-42847922 on Day 1. | Drug: JNJ-42847922<br>* Participants will receive JNJ-42847922 tablet as a single oral dose (Dose 1 or Dose 2 or Dose 3) on Day 1.<br>* Other names: Seltorexant;|
| Experimental: Part 1: Cohort 2 (JNJ-42847922)<br>Participants with mild hepatic impairment will receive Dose 1 of JNJ-42847922 on Day 1. | Drug: JNJ-42847922<br>* Participants will receive JNJ-42847922 tablet as a single oral dose (Dose 1 or Dose 2 or Dose 3) on Day 1.<br>* Other names: Seltorexant;|
| Experimental: Part 1: Cohort 3 (JNJ-42847922)<br>Participants with moderate hepatic impairment will receive Dose 2 of JNJ-42847922 on Day 1. | Drug: JNJ-42847922<br>* Participants will receive JNJ-42847922 tablet as a single oral dose (Dose 1 or Dose 2 or Dose 3) on Day 1.<br>* Other names: Seltorexant;|
| Experimental: Part 2: Cohort 4 (Optional) (JNJ-42847922)<br>Participants with moderate hepatic impairment will receive Dose 1 (depending on the results of Cohort 3) of JNJ-42847922 on Day 1. | Drug: JNJ-42847922<br>* Participants will receive JNJ-42847922 tablet as a single oral dose (Dose 1 or Dose 2 or Dose 3) on Day 1.<br>* Other names: Seltorexant;|
| Experimental: Part 2: Cohort 5 (Optional) (JNJ-42847922)<br>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. | Drug: JNJ-42847922<br>* Participants will receive JNJ-42847922 tablet as a single oral dose (Dose 1 or Dose 2 or Dose 3) on Day 1.<br>* Other names: Seltorexant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 |