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

Primary Purpose

Healthy, Hepatic Impairment

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

JNJ-42847922

About this trial

This is an interventional treatment trial for Healthy

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

CRS Clinical Research Services Kiel GmbH
APEX GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

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)

Arm Description

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

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

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

Participants with moderate hepatic impairment will receive Dose 1 (depending on the results of Cohort 3) of JNJ-42847922 on Day 1.

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04960124

First Posted

July 2, 2021

Last Updated

February 28, 2023

Sponsor

Janssen Research & Development, LLC

1. Study Identification

Unique Protocol Identification Number

NCT04960124

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

August 5, 2021 (Actual)

Primary Completion Date

November 19, 2021 (Actual)

Study Completion Date

November 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, Hepatic Impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1: Cohort 1 (JNJ-42847922)

Arm Type

Experimental

Arm Description

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

Arm Title

Part 1: Cohort 2 (JNJ-42847922)

Arm Type

Experimental

Arm Description

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

Arm Title

Part 1: Cohort 3 (JNJ-42847922)

Arm Type

Experimental

Arm Description

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

Arm Title

Part 2: Cohort 4 (Optional) (JNJ-42847922)

Arm Type

Experimental

Arm Description

Participants with moderate hepatic impairment will receive Dose 1 (depending on the results of Cohort 3) of JNJ-42847922 on Day 1.

Arm Title

Part 2: Cohort 5 (Optional) (JNJ-42847922)

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

JNJ-42847922

Other Intervention Name(s)

Seltorexant

Intervention Description

Participants will receive JNJ-42847922 tablet as a single oral dose (Dose 1 or Dose 2 or Dose 3) on Day 1.

Primary Outcome Measure Information:

Title

Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-42847922 and its Metabolites M12 and M16

Description

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

Time Frame

Pre-dose, up to 96 hours post-dose (up to Day 5)

Title

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

Description

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.

Time Frame

Pre-dose, up to 96 hours post-dose (up to Day 5)

Title

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

Description

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.

Time Frame

Pre-dose, up to 96 hours post-dose (up to Day 5)

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Up to Day 5

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Research & Development, LLC Clinical Trial

Organizational Affiliation

Janssen Research & Development, LLC

Official's Role

Study Director

Facility Information:

Facility Name

CRS Clinical Research Services Kiel GmbH

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

APEX GmbH

City

Munchen

ZIP/Postal Code

81241

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

IPD Sharing URL

https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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