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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Hepatic Impairment
• Intervention / Treatment: Drug: JNJ-42847922

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Kiel, Germany, 24105
    • CRS Clinical Research Services Kiel GmbH
  • Munchen, Germany, 81241
    • APEX GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2021
• Primary Completion (Actual): November 19, 2021
• Study Completion (Actual): November 19, 2021

Study Registration Dates

• First Submitted: July 2, 2021
• First Submitted That Met QC Criteria: July 2, 2021
• First Posted (Actual): July 13, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: CR108929; 2020-005235-69 (EudraCT Number); 42847922MDD1012 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No