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

NCT ID: NCT04208399

Last Updated: 2021-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-09
• Study Completion Date: 2021-03-26

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.

Conditions

Hepatic Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A: Group 1

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

Group Type: EXPERIMENTAL

JNJ-56136379

Intervention Type: DRUG

JNJ-56136379 will be administered orally in fed condition.

Part A: Group 2

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

Group Type: EXPERIMENTAL

JNJ-56136379

Intervention Type: DRUG

JNJ-56136379 will be administered orally in fed condition.

Part B: Group 3 (optional)

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

Group Type: EXPERIMENTAL

JNJ-56136379

Intervention Type: DRUG

JNJ-56136379 will be administered orally in fed condition.

Part B: Group 4 (optional)

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

Group Type: EXPERIMENTAL

JNJ-56136379

Intervention Type: DRUG

JNJ-56136379 will be administered orally in fed condition.

Interventions

JNJ-56136379

JNJ-56136379 will be administered orally in fed condition.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Sciences Ireland UC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Sciences Ireland UC Clinical Trials

Role: STUDY_DIRECTOR

Janssen Sciences Ireland UC

Locations

APEX GmbH

München, , Germany

Countries

Germany

Other Identifiers

2019-003071-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

56136379HPB1009

Identifier Type: OTHER

Identifier Source: secondary_id

CR108713

Identifier Type: -

Identifier Source: org_study_id