Healthy Clinical Trial
Official title:
An Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of JNJ-42847922 in Adult Participants
Verified date | March 2023 |
Source | Janssen Research & Development, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | November 19, 2021 |
Est. primary completion date | November 19, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 79 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | CRS Clinical Research Services Kiel GmbH | Kiel | |
Germany | APEX GmbH | Munchen |
Lead Sponsor | Collaborator |
---|---|
Janssen Research & Development, LLC |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-42847922 and its Metabolites M12 and M16 | Cmax is defined as maximum observed plasma analyte concentration of JNJ-42847922 and its metabolites M12 and M16. | Pre-dose, up to 96 hours post-dose (up to Day 5) | |
Primary | 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 | 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. | Pre-dose, up to 96 hours post-dose (up to Day 5) | |
Primary | 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 | 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. | Pre-dose, up to 96 hours post-dose (up to Day 5) | |
Secondary | Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability | 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. | Up to Day 5 |
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