A Study of JNJ-53718678 in Participants With Hepatic Impairment

Stopped early · Phase 1

Conditions studied: Hepatic Impairment

In brief

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.

Key facts

Study ID

NCT04332523

Run by

Janssen Research & Development, LLC

People needed

25

Starts

2020-08-17

Expected to finish

2022-03-16

Last updated by the study team

2022-06-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Orlando Clinical Research Center — Orlando, Florida, United States
• The Texas Liver Institute — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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