A Study of JNJ-53718678 in Participants With Hepatic Impairment

NCT04332523 | Terminated Phase 1 FDA Drug

• 2 other identifiers: CR10877353718678RSV1010
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hepatic Impairment

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Number of Participants with Adverse Events (AEs)

  From screening up to Day 14 (Up to 42 days)

Study Arms (4)

Group 1: Participants with Mild Hepatic Impairment

EXPERIMENTAL

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

Drug: JNJ-53718678

Group 2: Participants with Moderate Hepatic Impairment

EXPERIMENTAL

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

Drug: JNJ-53718678

Group 3: Participants with Severe Hepatic Impairment

EXPERIMENTAL

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

Drug: JNJ-53718678

Group 4: Participants with Normal Hepatic Function

EXPERIMENTAL

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

Drug: JNJ-53718678

Interventions

JNJ-53718678 DRUG

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

Also known as: Rilematovir

Group 1: Participants with Mild Hepatic Impairment; Group 2: Participants with Moderate Hepatic Impairment; Group 3: Participants with Severe Hepatic Impairment; Group 4: Participants with Normal Hepatic Function

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (2)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

The Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Interventions

JNJ-53718678

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 2, 2020
• Study Start: August 17, 2020
• Primary Completion: March 16, 2022
• Study Completion: March 16, 2022
• Last Updated: June 13, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share

Locations

US (2)