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

Phase 1

Completed

• Conditions: Hepatic Impairment
• Interventions: Drug: JNJ-56136379

• Registration Number: NCT04208399
• Lead Sponsor: Janssen Sciences Ireland UC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-20
• Study First Submitted QC: 2019-12-20
• Study First Posted: 2019-12-23
• Study Start: 2020-01-09
• Primary Completion: 2021-03-26
• Study Completion: 2021-03-26
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-19
• Last Update Posted: 2021-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part A: Group 1	JNJ-56136379	Participants with liver cirrhosis with moderate hepatic impairment will receive a single oral dose of JNJ-56136379 in fed condition.
Part B: Group 4 (optional)	JNJ-56136379	Participants with liver cirrhosis with severe hepatic impairment will receive a single oral dose of JNJ-56136379 in fed condition.
Part B: Group 3 (optional)	JNJ-56136379	Participants with liver cirrhosis with mild hepatic impairment will receive a single oral dose of JNJ-56136379 in fed condition.
Part A: Group 2	JNJ-56136379	Participants with normal liver function with no liver cirrhosis will receive a single oral dose of JNJ-56136379 in fed condition.

Primary Outcome Measures

Name	Time	Method
Plasma Concentration of JNJ-56136379	Up to Day 21	Plasma concentration of oral dose of JNJ-56136379 will be assessed.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Up to 6 months	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.

Trial Locations

Locations (1)

APEX GmbH; 🇩🇪 Munchen, Germany