A Study of JNJ-53718678 in Participants With Hepatic Impairment
NCT ID: NCT04332523
Last Updated: 2022-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
25 participants
INTERVENTIONAL
2020-08-17
2022-03-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1: Participants with Mild Hepatic Impairment
Participants with mild hepatic impairment will receive a single oral dose of JNJ-53718678 suspension on Day 1.
JNJ-53718678
Participants will receive a single oral dose of JNJ-53718678 suspension on Day 1.
Group 2: Participants with Moderate Hepatic Impairment
Participants with moderate hepatic impairment will receive a single oral dose of JNJ-53718678 suspension on Day 1.
JNJ-53718678
Participants will receive a single oral dose of JNJ-53718678 suspension on Day 1.
Group 3: Participants with Severe Hepatic Impairment
Participants with severe hepatic impairment will receive a single oral dose of JNJ-53718678 suspension on Day 1.
JNJ-53718678
Participants will receive a single oral dose of JNJ-53718678 suspension on Day 1.
Group 4: Participants with Normal Hepatic Function
Participants with normal hepatic function will receive a single oral dose of JNJ-53718678 suspension on Day 1.
JNJ-53718678
Participants will receive a single oral dose of JNJ-53718678 suspension on Day 1.
Interventions
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JNJ-53718678
Participants will receive a single oral dose of JNJ-53718678 suspension on Day 1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Orlando Clinical Research Center
Orlando, Florida, United States
The Texas Liver Institute
San Antonio, Texas, United States
Countries
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Other Identifiers
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53718678RSV1010
Identifier Type: OTHER
Identifier Source: secondary_id
CR108773
Identifier Type: -
Identifier Source: org_study_id
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