Healthy, Hepatic Impairment
Conditions
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.
Interventions
DRUGJNJ-42847922
Participants will receive JNJ-42847922 tablet as a single oral dose (Dose 1 or Dose 2 or Dose 3) on Day 1.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Outcome results
None listed