Overview

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

Status:
Recruiting
Trial end date:
2022-09-09
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Janssen Research & Development, LLC
Criteria
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