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A Study to Evaluate the Effect of Hepatic Impairment on JNJ-56136379

Primary Purpose

Hepatic Impairment

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
JNJ-56136379
Sponsored by
Janssen Sciences Ireland UC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Impairment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  • For all participants: Body mass index (BMI) between 18.0 and 38 kilogram per meter square (kg/m2), extremes included; Woman of childbearing potential must not be pregnant; Highly effective contraceptive measures in place for female participants of childbearing potential or male participants with female partners of childbearing potential; Non-smoker or light smoker as defined per protocol.
  • For Healthy Participants with Normal Hepatic Function and No Liver Cirrhosis: Demographically comparable to the study groups with hepatic impairment with respect to sex, age (+/-10 years), and body weight (+/-10 kilogram [kg]); Participants must be in good health clinically and biologically as defined per protocol.
  • For Participants with Liver Cirrhosis and Moderate or Mild or Severe Hepatic Impairment: Must have a 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; Must have liver cirrhosis with fibro scan readout greater than (>) 12.5 Kilopascal (kPa) as cut-off at screening
  • Participants with controlled hypertension, with problems directly associated with the primary diagnosis of hepatic impairment and with concurrent stable medical conditions if the condition(s) will not introduce an additional risk factor and will not interfere with the study objectives.
  • Concomitant medications to treat underlying disease states or medical conditions related to hepatic impairment are allowed.

Exclusion Criteria:

  • History of / or current clinically significant medical illness that could interfere with the interpretation of the study results.
  • Known allergies, hypersensitivity, or intolerance to JNJ-6379 or its excipients.
  • History of drug or alcohol abuse within 1 year before screening or positive test results at screening and Day -1.
  • Blood or blood products donated or substantial loss of blood (more than 500 milliliters [mL]) within 3 months before the study starts
  • Experimental drug received (including investigational vaccines) or experimental medical device used within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study intervention is scheduled.
  • Evidence of infection with human immunodeficiency virus (HIV)-1 and HIV-2, hepatitis A, B or C (except if sustained virologic response to hepatitis C virus [HCV] treatment).
  • Inability to fast for 10 hours.
  • Signs of hepatocellular carcinoma or history of biliary obstruction within the past 2 years.
  • Lack of good or reasonable venous access.

Sites / Locations

  • APEX GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Part A: Group 1

Part A: Group 2

Part B: Group 3 (optional)

Part B: Group 4 (optional)

Arm Description

Participants with liver cirrhosis with moderate hepatic impairment will receive a single oral dose of JNJ-56136379 in fed condition.

Participants with normal liver function with no liver cirrhosis will receive a single oral dose of JNJ-56136379 in fed condition.

Participants with liver cirrhosis with mild hepatic impairment will receive a single oral dose of JNJ-56136379 in fed condition.

Participants with liver cirrhosis with severe hepatic impairment will receive a single oral dose of JNJ-56136379 in fed condition.

Outcomes

Primary Outcome Measures

Plasma Concentration of JNJ-56136379
Plasma concentration of oral dose of JNJ-56136379 will be assessed.

Secondary Outcome Measures

Number of Participants with Adverse Events as a Measure of Safety and Tolerability
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

Full Information

First Posted
December 20, 2019
Last Updated
April 19, 2021
Sponsor
Janssen Sciences Ireland UC
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1. Study Identification

Unique Protocol Identification Number
NCT04208399
Brief Title
A Study to Evaluate the Effect of Hepatic Impairment on JNJ-56136379
Official Title
A Single-Dose, Open-Label, Parallel-Group Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of JNJ-56136379
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 9, 2020 (Actual)
Primary Completion Date
March 26, 2021 (Actual)
Study Completion Date
March 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Sciences Ireland UC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to evaluate the pharmacokinetics (PK) of a single oral dose of JNJ-56136379 in participants with liver cirrhosis and impaired hepatic function when compared with healthy participants with normal hepatic function and no liver cirrhosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A: Group 1
Arm Type
Experimental
Arm Description
Participants with liver cirrhosis with moderate hepatic impairment will receive a single oral dose of JNJ-56136379 in fed condition.
Arm Title
Part A: Group 2
Arm Type
Experimental
Arm Description
Participants with normal liver function with no liver cirrhosis will receive a single oral dose of JNJ-56136379 in fed condition.
Arm Title
Part B: Group 3 (optional)
Arm Type
Experimental
Arm Description
Participants with liver cirrhosis with mild hepatic impairment will receive a single oral dose of JNJ-56136379 in fed condition.
Arm Title
Part B: Group 4 (optional)
Arm Type
Experimental
Arm Description
Participants with liver cirrhosis with severe hepatic impairment will receive a single oral dose of JNJ-56136379 in fed condition.
Intervention Type
Drug
Intervention Name(s)
JNJ-56136379
Intervention Description
JNJ-56136379 will be administered orally in fed condition.
Primary Outcome Measure Information:
Title
Plasma Concentration of JNJ-56136379
Description
Plasma concentration of oral dose of JNJ-56136379 will be assessed.
Time Frame
Up to Day 21
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: For all participants: Body mass index (BMI) between 18.0 and 38 kilogram per meter square (kg/m2), extremes included; Woman of childbearing potential must not be pregnant; Highly effective contraceptive measures in place for female participants of childbearing potential or male participants with female partners of childbearing potential; Non-smoker or light smoker as defined per protocol. For Healthy Participants with Normal Hepatic Function and No Liver Cirrhosis: Demographically comparable to the study groups with hepatic impairment with respect to sex, age (+/-10 years), and body weight (+/-10 kilogram [kg]); Participants must be in good health clinically and biologically as defined per protocol. For Participants with Liver Cirrhosis and Moderate or Mild or Severe Hepatic Impairment: Must have a 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; Must have liver cirrhosis with fibro scan readout greater than (>) 12.5 Kilopascal (kPa) as cut-off at screening Participants with controlled hypertension, with problems directly associated with the primary diagnosis of hepatic impairment and with concurrent stable medical conditions if the condition(s) will not introduce an additional risk factor and will not interfere with the study objectives. Concomitant medications to treat underlying disease states or medical conditions related to hepatic impairment are allowed. Exclusion Criteria: History of / or current clinically significant medical illness that could interfere with the interpretation of the study results. Known allergies, hypersensitivity, or intolerance to JNJ-6379 or its excipients. History of drug or alcohol abuse within 1 year before screening or positive test results at screening and Day -1. Blood or blood products donated or substantial loss of blood (more than 500 milliliters [mL]) within 3 months before the study starts Experimental drug received (including investigational vaccines) or experimental medical device used within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study intervention is scheduled. Evidence of infection with human immunodeficiency virus (HIV)-1 and HIV-2, hepatitis A, B or C (except if sustained virologic response to hepatitis C virus [HCV] treatment). Inability to fast for 10 hours. Signs of hepatocellular carcinoma or history of biliary obstruction within the past 2 years. Lack of good or reasonable venous access.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Sciences Ireland UC Clinical Trials
Organizational Affiliation
Janssen Sciences Ireland UC
Official's Role
Study Director
Facility Information:
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 & 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-56136379

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