A Phase 1 interventional study of JNJ-53718678 in Hepatic Impairment, sponsored by Janssen Research & Development, LLC. Terminated at 2 sites in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-13.
Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Treatment
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.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 25 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.
Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants with mild hepatic impairment will receive a single oral dose of JNJ-53718678 suspension on Day 1.
Drug: JNJ-53718678
Participants with moderate hepatic impairment will receive a single oral dose of JNJ-53718678 suspension on Day 1.
Drug: JNJ-53718678
Participants with severe hepatic impairment will receive a single oral dose of JNJ-53718678 suspension on Day 1.
Drug: JNJ-53718678
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.
Also known as: Rilematovir
Maximum Plasma Concentration (Cmax) of JNJ-53718678
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
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.
Time frame: Predose, 15 min, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h and 96h postdose
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.
Time frame: Predose, 15 min, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h and 96h postdose
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.
Time frame: From screening up to Day 14 (Up to 42 days)
Plan to share: Yes — 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
No publications or documents are linked to this record.
This study is terminated, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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