A Study to Evaluate the Effect of Hepatic Impairment on JNJ-42847922 in Adult Participants
- Registration Number
- NCT04960124
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: Cohort 2 (JNJ-42847922) JNJ-42847922 Participants with mild hepatic impairment will receive Dose 1 of JNJ-42847922 on Day 1. Part 1: Cohort 1 (JNJ-42847922) JNJ-42847922 Participants with normal hepatic function will receive Dose 1 of JNJ-42847922 on Day 1. Part 1: Cohort 3 (JNJ-42847922) JNJ-42847922 Participants with moderate hepatic impairment will receive Dose 2 of JNJ-42847922 on Day 1. Part 2: Cohort 4 (Optional) (JNJ-42847922) JNJ-42847922 Participants with moderate hepatic impairment will receive Dose 1 (depending on the results of Cohort 3) of JNJ-42847922 on Day 1. Part 2: Cohort 5 (Optional) (JNJ-42847922) JNJ-42847922 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.
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-42847922 and its Metabolites M12 and M16 Pre-dose, up to 96 hours post-dose (up to Day 5) Cmax is defined as maximum observed plasma analyte concentration of JNJ-42847922 and its metabolites M12 and M16.
Area Under Plasma Analyte Concentration versus Time Curve from Time Zero to Time of Last Measurable Concentration (AUC [0-last]) of JNJ-42847922 and its Metabolites M12 and M16 Pre-dose, up to 96 hours post-dose (up to Day 5) AUC(0-last) is defined as area under the plasma analyte concentration versus time curve from time zero to time of last measurable concentration of JNJ-42847922 and its metabolites M12 and M16.
Area Under the Plasma Analyte Concentration versus Time Curve from Time Zero to Infinite Time (AUC[0-Infinity]) of JNJ-42847922 and its Metabolites M12 and M16 Pre-dose, up to 96 hours post-dose (up to Day 5) AUC(0-infinity) is defined as the area under the plasma analyte concentration versus time curve from time zero to infinite time of JNJ-42847922 and its metabolites M12 and M16.
- Secondary Outcome Measures
Name Time Method Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability Up to Day 5 An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Trial Locations
- Locations (2)
APEX GmbH
🇩🇪Munchen, Germany
CRS Clinical Research Services Kiel GmbH
🇩🇪Kiel, Germany