Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rilematovir · 1 trial · 1 indication
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...
Rilematovir is an investigational small molecule being studied in healthy adult participants. It is not approved for any disease and is currently in clinical development. The only completed trial assessed its interaction with ciclosporin in healthy volunteers, not a specific medical condition.
Rilematovir is being developed by Johnson & Johnson (NYSE: JNJ). The company sponsored a Phase 1 clinical trial of the drug in healthy participants. As of the available data, Rilematovir remains an investigational compound in early-stage development.
Rilematovir is in Phase 1 clinical development. One Phase 1 study has been completed, involving 18 healthy adult participants in Belgium. The drug is investigational and has not been approved by regulatory authorities. No later-phase trials have been reported.
Rilematovir has one completed clinical trial, NCT05155007, titled "A Study in Healthy Adult Participants to Assess the Effects of Ciclosporin Administration on Rilematovir." This Phase 1 study enrolled 18 healthy adults in Belgium and evaluated a potential drug interaction.
Rilematovir is not FDA approved. It is an investigational drug in Phase 1 clinical development. The only completed trial was a pharmacokinetic interaction study in healthy volunteers. No approval applications have been submitted, and the drug remains under clinical investigation.