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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003801-23 | EudraCT Number | ||
| 53718678RSV1014 | Other Identifier | Janssen Research & Development, LLC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence ABC | Experimental | 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. |
|
| Treatment Sequence BCA | Experimental | 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. |
|
| Treatment Sequence CAB | Experimental | 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. |
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| Treatment Sequence ACB | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rilematovir | Drug | Rilematovir will be administered orally as per assigned treatment sequence. |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment A and Treatment C: Maximum Observed Plasma Analyte Concentration (Cmax) of Rilematovir | Cmax is defined as maximum observed plasma analyte concentration of rilematovir. | 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. | 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. | 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. | 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. | Pre-dose up to 96 hours |
| Treatment A and Treatment C: Total Apparent Oral Clearance (CL/F) of Rilematovir |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Unit | Merksem | 2170 | Belgium |
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
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| ID | Term |
|---|---|
| C000624632 | JNJ-53718678 |
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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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.
|
| Treatment Sequence BAC | Experimental | 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. |
|
| Treatment Sequence CBA | Experimental | 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. |
|
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| Ciclosporin | Drug | Ciclosporin will be administered orally as per assigned treatment sequence. |
|
CL/F is defined as total apparent oral clearance of rilematovir. |
| Pre-dose up to 96 hours |
Tmax is defined as the actual sampling time to reach the maximum observed whole blood analyte concentration of ciclosporin. |
| 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. | 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. | 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. | 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. | 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. | Up to Week 12 |
| Percentage of Participants with Abnormalities in Electrocardiogram (ECG) | Percentage of participants with abnormalities in ECG will be reported. | 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. | 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. | 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. | Up to Week 12 |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |