A Study of JNJ-53718678 in Participants With Hepatic Impairment

Recruitment & Eligibility

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

Study & Design

Arm && Interventions

Group	Intervention	Description
Group 2: Participants with Moderate Hepatic Impairment	JNJ-53718678	Participants with moderate hepatic impairment will receive a single oral dose of JNJ-53718678 suspension on Day 1.
Group 4: Participants with Normal Hepatic Function	JNJ-53718678	Participants with normal hepatic function will receive a single oral dose of JNJ-53718678 suspension on Day 1.
Group 1: Participants with Mild Hepatic Impairment	JNJ-53718678	Participants with mild hepatic impairment will receive a single oral dose of JNJ-53718678 suspension on Day 1.
Group 3: Participants with Severe Hepatic Impairment	JNJ-53718678	Participants with severe hepatic impairment will receive a single oral dose of JNJ-53718678 suspension on Day 1.

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.

Recruitment & Eligibility