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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment; Healthy

Treatments: Drug: JNJ-42847922

Study type: Interventional

Funder types: Industry

Identifiers

NCT04960124

2020-005235-69 (EudraCT Number)

42847922MDD1012 (Other Identifier)

CR108929

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 5 patient groups

Part 1: Cohort 1 (JNJ-42847922)

Experimental group

Description:

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

Treatment:

Drug: JNJ-42847922

Part 1: Cohort 2 (JNJ-42847922)

Experimental group

Description:

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

Treatment:

Drug: JNJ-42847922

Part 1: Cohort 3 (JNJ-42847922)

Experimental group

Description:

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

Treatment:

Drug: JNJ-42847922

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

Experimental group

Description:

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

Treatment:

Drug: JNJ-42847922

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

Experimental group

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.

Treatment:

Drug: JNJ-42847922