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A Study of JNJ-53718678 in Participants With Hepatic Impairment

Primary Purpose

Hepatic Impairment

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
JNJ-53718678
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Impairment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Orlando Clinical Research Center
  • The Texas Liver Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

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

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Maximum Plasma Concentration (Cmax) of JNJ-53718678
Cmax is defined as the maximum plasma concentration of JNJ-53718678.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 1, 2020
Last Updated
June 9, 2022
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04332523
Brief Title
A Study of JNJ-53718678 in Participants With Hepatic Impairment
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
A strategic decision was made to discontinue the study. The decision was not based on a safety concern.
Study Start Date
August 17, 2020 (Actual)
Primary Completion Date
March 16, 2022 (Actual)
Study Completion Date
March 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Participants with Mild Hepatic Impairment
Arm Type
Experimental
Arm Description
Participants with mild hepatic impairment will receive a single oral dose of JNJ-53718678 suspension on Day 1.
Arm Title
Group 2: Participants with Moderate Hepatic Impairment
Arm Type
Experimental
Arm Description
Participants with moderate hepatic impairment will receive a single oral dose of JNJ-53718678 suspension on Day 1.
Arm Title
Group 3: Participants with Severe Hepatic Impairment
Arm Type
Experimental
Arm Description
Participants with severe hepatic impairment will receive a single oral dose of JNJ-53718678 suspension on Day 1.
Arm Title
Group 4: Participants with Normal Hepatic Function
Arm Type
Experimental
Arm Description
Participants with normal hepatic function will receive a single oral dose of JNJ-53718678 suspension on Day 1.
Intervention Type
Drug
Intervention Name(s)
JNJ-53718678
Other Intervention Name(s)
Rilematovir
Intervention Description
Participants will receive a single oral dose of JNJ-53718678 suspension on Day 1.
Primary Outcome Measure Information:
Title
Maximum Plasma Concentration (Cmax) of JNJ-53718678
Description
Cmax is defined as the maximum plasma concentration of JNJ-53718678.
Time Frame
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
Title
Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUClast) of JNJ-53718678
Description
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.
Time Frame
Predose, 15 min, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h and 96h postdose
Title
Area Under the Plasma Concentration-time Curve From Time 0 to Infinite Time (AUC[0-infinity])
Description
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.
Time Frame
Predose, 15 min, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h and 96h postdose
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events (AEs)
Description
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.
Time Frame
From screening up to Day 14 (Up to 42 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
The Texas Liver Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

A Study of JNJ-53718678 in Participants With Hepatic Impairment

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