A Study of JNJ-53718678 in Participants With Hepatic Impairment
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: JNJ-53718678
Participants will receive a single oral dose of JNJ-53718678 suspension on Day 1.
Other Names:
|
| Experimental: 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. |
Drug: JNJ-53718678
Participants will receive a single oral dose of JNJ-53718678 suspension on Day 1.
Other Names:
|
| Experimental: 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. |
Drug: JNJ-53718678
Participants will receive a single oral dose of JNJ-53718678 suspension on Day 1.
Other Names:
|
| Experimental: 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. |
Drug: JNJ-53718678
Participants will receive a single oral dose of JNJ-53718678 suspension on Day 1.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Maximum Plasma Concentration (Cmax) 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]
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 [Predose, 15 min, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h and 96h postdose]
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]) [Predose, 15 min, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h and 96h postdose]
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) [From screening up to Day 14 (Up to 42 days)]
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.
Eligibility Criteria
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
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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
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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
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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:
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Known allergies, hypersensitivity, or intolerance to JNJ-53718678 or its excipients
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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
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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
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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
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Preplanned surgery or procedures that would interfere with the conduct of the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Orlando Clinical Research Center | Orlando | Florida | United States | 32809 |
| 2 | The Texas Liver Institute | San Antonio | Texas | United States | 78215 |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR108773
- 53718678RSV1010