A Phase 1 interventional study of Rilematovir and Ciclosporin in Healthy, sponsored by Janssen Research & Development, LLC. Completed at 1 site in Belgium. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 1, Interventional, and Basic science
The purpose of this study is to evaluate the pharmacokinetic (PK) of a single-dose of rilematovir co-administered with a single-dose of ciclosporin compared to a single-dose administration of rilematovir alone.
Janssen Research & Development, LLC is the lead sponsor of 929 studies on the registry; 76 are open to participants now.
Of its 283 completed or terminated interventional studies of FDA-regulated products, 134 (47%) have results posted.
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Exclusion Criteria:
Participants will receive a single oral dose of rilematovir (Treatment A) in Treatment Period 1, followed by a single oral dose of ciclosporin (Treatment B) in Treatment Period 2 and then single oral dose of ciclosporin plus single oral dose of rilematovir (Treatment C) in Treatment Period 3 on Day 1 of each Treatment Period under fasted conditions. Each treatment period will be separated by a washout period of at least 5 days and maximum 21 days between subsequent intakes of study intervention.
Drug: Rilematovir · Drug: Ciclosporin
Participants will receive Treatment B in Treatment Period 1, followed by Treatment C in Treatment Period 2 and then Treatment A in Treatment Period 3 on Day 1 of each Treatment Period under fasted conditions. Each treatment period will be separated by a washout period of at least 5 days and maximum 21 days between subsequent intakes of study intervention.
Drug: Rilematovir · Drug: Ciclosporin
Participants will receive Treatment C in Treatment Period 1, followed by Treatment A in Treatment Period 2 and then Treatment B in Treatment Period 3 on Day 1 of each Treatment Period under fasted conditions. Each treatment period will be separated by a washout period of at least 5 days and maximum 21 days between subsequent intakes of study intervention.
Drug: Rilematovir · Drug: Ciclosporin
Participants will receive Treatment A in Treatment Period 1, followed by Treatment C in Treatment Period 2 and then Treatment B in Treatment Period 3 on Day 1 of each Treatment Period under fasted conditions. Each treatment period will be separated by a washout period of at least 5 days and maximum 21 days between subsequent intakes of study intervention.
Drug: Rilematovir · Drug: Ciclosporin
Participants will receive Treatment B in Treatment Period 1, followed by Treatment A in Treatment Period 2 and then Treatment C in Treatment Period 3 on Day 1 of each Treatment Period under fasted conditions. Each treatment period will be separated by a washout period of at least 5 days and maximum 21 days between subsequent intakes of study intervention.
Drug: Rilematovir · Drug: Ciclosporin
Participants will receive Treatment C in Treatment Period 1, followed by Treatment B in Treatment Period 2 and then Treatment A in Treatment Period 3 on Day 1 of each Treatment Period under fasted conditions. Each treatment period will be separated by a washout period of at least 5 days and maximum 21 days between subsequent intakes of study intervention.
Drug: Rilematovir · Drug: Ciclosporin
Rilematovir will be administered orally as per assigned treatment sequence.
Also known as: JNJ-53718678
Ciclosporin will be administered orally as per assigned treatment sequence.
Treatment A and Treatment C: Maximum Observed Plasma Analyte Concentration (Cmax) of Rilematovir
Cmax is defined as maximum observed plasma analyte concentration of rilematovir.
Time frame: Pre-dose up to 24 hours
Treatment A and Treatment C: The Actual Sampling Time to Reach the Maximum Observed Plasma Analyte Concentration (Tmax) of Rilematovir
Tmax is defined as the actual sampling time to reach the maximum observed plasma analyte concentration of rilematovir.
Time frame: Pre-dose up to 24 hours
Treatment A and Treatment C: Apparent Terminal Elimination Half-life (T1/2) of Rilematovir
T1/2 is defined as the apparent terminal elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve.
Time frame: Pre-dose up to 96 hours
Treatment A and Treatment C: Area Under the Plasma Analyte Concentration Versus Time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC[0-last]) of Rilematovir
AUC(0-last) is defined as area under the plasma analyte concentration versus time curve from time zero to the time of the last measurable concentration of rilematovir.
Time frame: Pre-dose up to 96 hours
Treatment A and Treatment C: Area Under the Plasma Analyte Concentration Versus Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Rilematovir
AUC(0-infinity) is defined as area under the plasma analyte concentration versus time curve from time zero to infinite time of rilematovir.
Time frame: Pre-dose up to 96 hours
Treatment A and Treatment C: Total Apparent Oral Clearance (CL/F) of Rilematovir
CL/F is defined as total apparent oral clearance of rilematovir.
Time frame: Pre-dose up to 96 hours
Treatment B and Treatment C: Maximum Observed Whole Blood Analyte Concentration (Cmax) of Ciclosporin
Cmax is defined as maximum observed whole blood analyte concentration of ciclosporin.
Time frame: Pre-dose up to 24 hours
Treatment B and Treatment C: The Actual Sampling Time to Reach the Maximum Observed Whole Blood Analyte Concentration (Tmax) of Ciclosporin
Tmax is defined as the actual sampling time to reach the maximum observed whole blood analyte concentration of ciclosporin.
Time frame: Pre-dose up to 24 hours
Treatment B and Treatment C: Apparent Terminal Elimination Half-life (T1/2) of Ciclosporin
T1/2 is defined as apparent terminal elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve.
Time frame: Pre-dose up to 96 hours
Treatment B and Treatment C: Area Under the Whole Blood Analyte Concentration Versus Time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC[0-last]) of Ciclosporin
AUC(0-last) is defined as area under the whole blood analyte concentration versus time curve from time zero to the time of the last measurable concentration of ciclosporin.
Time frame: Pre-dose up to 96 hours
Treatment B and Treatment C: Area Under the Whole Blood Analyte Concentration Versus Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Ciclosporin
AUC(0-infinity) is defined as area under the whole blood analyte concentration versus time curve from time Zero to infinite time of ciclosporin.
Time frame: Pre-dose up to 96 hours
Treatment B and Treatment C: Total Apparent Oral Clearance (CL/F) of Ciclosporin
CL/F is defined as total apparent oral clearance of ciclosporin.
Time frame: Pre-dose up to 96 hours
Percentage of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
Time frame: Up to Week 12
Percentage of Participants with Abnormalities in Electrocardiogram (ECG)
Percentage of participants with abnormalities in ECG will be reported.
Time frame: Up to Week 12
Percentage of Participants with Abnormalities in Physical Examination
Percentage of participants with abnormalities in physical examination (including height, body weight and examination of all body systems and dermatologic examinations) will be reported.
Time frame: Up to Week 12
Percentage of Participants with Abnormalities in Vital Signs
Percentage of participants with abnormalities in vital signs (including temperature \[tympanic\], pulse/heart rate, blood pressure \[systolic and diastolic\]) will be reported.
Time frame: Up to Week 12
Percentage of Participants with Abnormalities in Clinical Laboratory Tests
Percentage of participants with abnormalities in clinical laboratory tests (including serum chemistry, hematology and routine urinalysis) will be reported.
Time frame: Up to Week 12
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
Data sharing details ↗ · www.janssen.com
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: JNJ-53718678 · Cyclosporine
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