Hepatic Impairment
Conditions
Brief summary
The main purpose of the study is to evaluate the pharmacokinetc (PK) of a single oral dose of JNJ-53718678 in participants with varying degrees of impaired hepatic function (mild, moderate, and severe) when compared with participants with normal hepatic function.
Interventions
DRUGJNJ-53718678
Participants will receive a single oral dose of JNJ-53718678 suspension 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 75 Years
Healthy volunteers
Yes
Inclusion criteria
* A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin \[beta-HCG\]) test at screening and on Day -1 of the treatment period * Contraceptive use by female participants or women should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies * If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 30 days after receiving the study drug * A male participant must agree not to donate sperm for the purpose of reproduction from Day -1 of the study and for a minimum of 90 days after receiving the study drug * For participants with mild, moderate or severe hepatic impairment: the participants must have a total Child-Pugh score of 5 to 6, inclusive (mild); or 7 to 9, inclusive (moderate); or 10-15, inclusive (severe). The Investigator will determine degree of hepatic impairment
Exclusion criteria
* Known allergies, hypersensitivity, or intolerance to JNJ-53718678 or its excipients * Donated blood or blood products or had substantial loss of blood (more than 500 milliliter \[mL\]) within 90 days before the administration of study drug or intention to donate blood or blood products during the study * Received an experimental drug (including investigational vaccines) or used an experimental medical device within 30 days or within a period less than 5 times the drug's half-life, whichever is longer, before the dose of the study drug is scheduled * Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments * Preplanned surgery or procedures that would interfere with the conduct of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of JNJ-53718678 | Predose, 15 minutes (min), 30 min, 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h and 96h postdose | Cmax is defined as the maximum plasma concentration of JNJ-53718678. |
| Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUClast) of JNJ-53718678 | Predose, 15 min, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h and 96h postdose | AUClast is defined as the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration of JNJ-53718678. |
| Area Under the Plasma Concentration-time Curve From Time 0 to Infinite Time (AUC[0-infinity]) | Predose, 15 min, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h and 96h postdose | AUC(0-infinity) is defined as the area under the plasma concentration-time curve from time 0 to infinite time calculated as the sum of AUClast and Clast/lz, in which Clast is the last observed quantifiable concentration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | From screening up to Day 14 (Up to 42 days) | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. |
Countries
United States
Outcome results
None listed