A Study of JNJ-53718678 in Participants With Hepatic Impairment

Hepatic Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04332523
• Other study ID #: CR108773
• Secondary ID: 53718678RSV1010
• Status: Terminated
• Phase: Phase 1
• Start date: August 17, 2020
• Est. completion date: March 16, 2022

Study information

• Verified date: June 2022
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: March 16, 2022
• Est. primary completion date: March 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

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

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• JNJ-53718678
Participants will receive a single oral dose of JNJ-53718678 suspension on Day 1.

Locations

Country	Name	City	State
United States	Orlando Clinical Research Center	Orlando	Florida
United States	The Texas Liver Institute	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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)