Status:
TERMINATED
A Study of JNJ-53718678 in Participants With Hepatic Impairment
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Hepatic Impairment
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04332523
Start Date
August 17 2020
End Date
March 16 2022
Last Update
June 13 2022
Active Locations (2)
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1
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
2
The Texas Liver Institute
San Antonio, Texas, United States, 78215