Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Janssen Research & Development, LLC
Age
18–75
Sex
ALL
Healthy volunteers
Accepted
You may be eligible 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 be 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
