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

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT04960124
Collaborator
(none)
24
Enrollment
2
Locations
5
Arms
3.5
Actual Duration (Months)
12
Patients Per Site
3.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Aug 5, 2021
Actual Primary Completion Date :
Nov 19, 2021
Actual Study Completion Date :
Nov 19, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-42847922 and its Metabolites M12 and M16 [Pre-dose, up to 96 hours post-dose (up to Day 5)]

      Cmax is defined as maximum observed plasma analyte concentration of JNJ-42847922 and its metabolites M12 and M16.

    2. 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 [Pre-dose, up to 96 hours post-dose (up to Day 5)]

      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.

    3. 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 [Pre-dose, up to 96 hours post-dose (up to Day 5)]

      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.

    Secondary Outcome Measures

    1. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [Up to Day 5]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 79 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CRS Clinical Research Services Kiel GmbH Kiel Germany 24105
    2 APEX GmbH Munchen Germany 81241

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

    • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT04960124
    Other Study ID Numbers:
    • CR108929
    • 2020-005235-69
    • 42847922MDD1012
    First Posted:
    Jul 13, 2021
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Liver Diseases

    Study Results

    No Results Posted as of Mar 31, 2022