A Study of JNJ-53718678 in Participants With Hepatic Impairment

Study Overview
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Brief Summary
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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.

Official Title
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A Single-Dose, Open-Label, Parallel-Group Study to Evaluate the Effect of Mild, Moderate, and Severe Hepatic Impairment on the Pharmacokinetics of JNJ-53718678

Conditions
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Hepatic Impairment

Intervention / Treatment
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* Drug: JNJ-53718678


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Participants with Mild Hepatic Impairment<br>Participants with mild hepatic impairment will receive a single oral dose of JNJ-53718678 suspension on Day 1. | Drug: JNJ-53718678<br>* Participants will receive a single oral dose of JNJ-53718678 suspension on Day 1.<br>* Other names: Rilematovir;|
| Experimental: Group 2: Participants with Moderate Hepatic Impairment<br>Participants with moderate hepatic impairment will receive a single oral dose of JNJ-53718678 suspension on Day 1. | Drug: JNJ-53718678<br>* Participants will receive a single oral dose of JNJ-53718678 suspension on Day 1.<br>* Other names: Rilematovir;|
| Experimental: Group 3: Participants with Severe Hepatic Impairment<br>Participants with severe hepatic impairment will receive a single oral dose of JNJ-53718678 suspension on Day 1. | Drug: JNJ-53718678<br>* Participants will receive a single oral dose of JNJ-53718678 suspension on Day 1.<br>* Other names: Rilematovir;|
| Experimental: Group 4: Participants with Normal Hepatic Function<br>Participants with normal hepatic function will receive a single oral dose of JNJ-53718678 suspension on Day 1. | Drug: JNJ-53718678<br>* Participants will receive a single oral dose of JNJ-53718678 suspension on Day 1.<br>* Other names: Rilematovir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration (Cmax) of JNJ-53718678 | Cmax is defined as the maximum plasma concentration 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 | 
| Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUClast) of JNJ-53718678 | 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. | Predose, 15 min, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h and 96h postdose | 
| Area Under the Plasma Concentration-time Curve From Time 0 to Infinite Time (AUC[0-infinity]) | 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. | Predose, 15 min, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h and 96h postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events (AEs) | 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. | From screening up to Day 14 (Up to 42 days) |