A Phase 1 interventional study of Pimodivir and Cyclosporine in Healthy, sponsored by Janssen-Cilag International NV. Completed at 1 site in Belgium. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-29.
Sponsored by Janssen-Cilag International NV (part of Johnson & Johnson) · Phase 1, Interventional, and Other
The purpose of this study is to evaluate the effect of a single oral dose of cyclosporine on the pharmacokinetics of a single oral dose of pimodivir when coadministered to healthy adult participants under fasted conditions.
Janssen-Cilag International NV is the lead sponsor of 67 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Participants will receive Treatment A (pimodivir 600 milligram \[mg\] orally as two tablets of 300 mg each) on Day 1 in Period 1 followed by Treatment B (pimodivir 600 mg as two tablets of 300 mg each plus cyclosporine 400 mg orally as four capsules of 100 mg each) on Day 1 in Period 2. Study drug intake in subsequent treatment periods will be separated by a washout period of at least 14 days.
Drug: Pimodivir · Drug: Cyclosporine
Participants will receive Treatment B on Day 1 in Period 1 followed by Treatment A on Day 1 in Period 2. Study drug intake in subsequent treatment periods will be separated by a washout period of at least 14 days.
Drug: Pimodivir · Drug: Cyclosporine
Participants will be administered pimodivir 600 mg orally as two tablets of 300 mg each.
Also known as: JNJ-63623872
Participants will be administered cyclosporine 400 mg orally as 4 capsules of 100 mg each.
Also known as: NEORAL
Maximum Observed Plasma Concentration (Cmax)
Cmax is defined as maximum observed plasma concentration.
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6 , 8, 12, 16, 24, 48, 72, 96, 120, 144, 168 hours postdose on Day 8
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration Time (AUC [0-Last])
AUC(0-Last) is area under the plasma concentration-time curve from time zero to time of the last measurable (non-below quantification limit) concentration, calculated by linear-linear trapezoidal summation.
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6 , 8, 12, 16, 24, 48, 72, 96, 120, 144, 168 hours postdose on Day 8
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); where C(last) is the last observed measurable (non-below quantification limit) concentration.
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6 , 8, 12, 16, 24, 48, 72, 96, 120, 144, 168 hours postdose on Day 8
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
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: Approximately 65 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 Access (YODA) Project site at yoda.yale.edu
Data sharing details ↗ · www.janssen.com
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Pimodivir · Cyclosporine
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