A Study of JNJ-53718678 in Participants With Hepatic Impairment

Janssen (J&J Innovative Medicine)

Status and phase: Terminated; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: JNJ-53718678

Study type: Interventional

Funder types: Industry

Identifiers

NCT04332523

CR108773

53718678RSV1010 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 4 patient groups

Group 1: Participants with Mild Hepatic Impairment

Experimental group

Description:

Participants with mild hepatic impairment will receive a single oral dose of JNJ-53718678 suspension on Day 1.

Treatment:

Drug: JNJ-53718678

Group 2: Participants with Moderate Hepatic Impairment

Experimental group

Description:

Participants with moderate hepatic impairment will receive a single oral dose of JNJ-53718678 suspension on Day 1.

Treatment:

Drug: JNJ-53718678

Group 3: Participants with Severe Hepatic Impairment

Experimental group

Description:

Participants with severe hepatic impairment will receive a single oral dose of JNJ-53718678 suspension on Day 1.

Treatment:

Drug: JNJ-53718678

Group 4: Participants with Normal Hepatic Function

Experimental group

Description:

Participants with normal hepatic function will receive a single oral dose of JNJ-53718678 suspension on Day 1.

Treatment:

Drug: JNJ-53718678