Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05155007 | A Study in Healthy Adult Participants to Assess the Effects of Ciclosporin Administration on Rilematovir | PHASE1 | COMPLETED | 18 | — | — | Dec 10, 2021 | Feb 4, 2022 | Feb 3, 2025 | 1 | Belgium |
Cmax is defined as maximum observed plasma analyte concentration of rilematovir.
Tmax is defined as the actual sampling time to reach the maximum observed plasma analyte concentration 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.
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.
AUC(0-infinity) is defined as area under the plasma analyte concentration versus time curve from time zero to infinite time of rilematovir.
CL/F is defined as total apparent oral clearance of rilematovir.
| Arm | Type | Description |
|---|---|---|
| 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. |
| Treatment Sequence ACB | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| Rilematovir | DRUG | Rilematovir will be administered orally as per assigned treatment sequence. |
| Ciclosporin | DRUG | Ciclosporin will be administered orally as per assigned treatment sequence. |
Inclusion Criteria: * Body weight not less than 50 kilograms (kg) and body mass index (BMI; weight kg/height\^2 \[meter {m\^2}\]) within the range 18.0 to 30.0 kilograms per meter square (kg/m\^2) (inclusive) * Female participants, except those that are of non-childbearing potential, must have a ne...