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

NCT04208399 | Completed Phase 1 FDA Drug

• 3 other identifiers: CR1087132019-003071-2056136379HPB1009
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Plasma Concentration of JNJ-56136379

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

  Up to Day 21

Secondary Outcomes (1)

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

  Up to 6 months

Study Arms (4)

Part A: Group 1

EXPERIMENTAL

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

Drug: JNJ-56136379

Part A: Group 2

EXPERIMENTAL

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

Drug: JNJ-56136379

Part B: Group 3 (optional)

EXPERIMENTAL

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

Drug: JNJ-56136379

Part B: Group 4 (optional)

EXPERIMENTAL

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

Drug: JNJ-56136379

Interventions

JNJ-56136379 DRUG

JNJ-56136379 will be administered orally in fed condition.

Part A: Group 1; Part A: Group 2; Part B: Group 3 (optional); Part B: Group 4 (optional)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Janssen Sciences Ireland UC: lead

Study Sites (1)

APEX GmbH

München, 81241, Germany

Location

MeSH Terms

Interventions

JNJ-56136379

Study Officials

• Janssen Sciences Ireland UC Clinical Trials

  Janssen Sciences Ireland UC

  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: December 20, 2019
• First Posted: December 23, 2019
• Study Start: January 9, 2020
• Primary Completion: March 26, 2021
• Study Completion: March 26, 2021
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)