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

NCT04960124 | Completed Phase 1 FDA Drug

• 3 other identifiers: CR1089292020-005235-6942847922MDD1012
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Healthy; Hepatic Impairment

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

  Up to Day 5

Study Arms (5)

Part 1: Cohort 1 (JNJ-42847922)

EXPERIMENTAL

Participants with normal hepatic function will receive Dose 1 of JNJ-42847922 on Day 1.

Drug: JNJ-42847922

Part 1: Cohort 2 (JNJ-42847922)

EXPERIMENTAL

Participants with mild hepatic impairment will receive Dose 1 of JNJ-42847922 on Day 1.

Drug: JNJ-42847922

Part 1: Cohort 3 (JNJ-42847922)

EXPERIMENTAL

Participants with moderate hepatic impairment will receive Dose 2 of JNJ-42847922 on Day 1.

Drug: JNJ-42847922

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.

Drug: JNJ-42847922

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.

Drug: JNJ-42847922

Interventions

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.

Also known as: Seltorexant

Part 1: Cohort 1 (JNJ-42847922); Part 1: Cohort 2 (JNJ-42847922); Part 1: Cohort 3 (JNJ-42847922); Part 2: Cohort 4 (Optional) (JNJ-42847922); Part 2: Cohort 5 (Optional) (JNJ-42847922)

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (2)

CRS Clinical Research Services Kiel GmbH

Kiel, 24105, Germany

Location

APEX GmbH

München, 81241, Germany

Location

MeSH Terms

Interventions

seltorexant

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 13, 2021
• Study Start: August 5, 2021
• Primary Completion: November 19, 2021
• Study Completion: November 19, 2021
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

DE (2)