Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Maribavir Commercial Tablet Formulation
Maribavir Commercial Formulation · 1 trial · 1 indication
Cmax was defined as maximum observed concentration of maribavir in plasma.
AUClast was defined as the area under the concentration-time curve from time 0 to the time of the last quantifiable concentration of maribavir in plasma.
AUC0-infinity was defined as the area under the plasma concentration-time curve from time 0 to infinity of maribavir in plasma.
| Arm | Type | Description |
|---|---|---|
| Part 1, Sequence 1: Treatment A + Treatment B + Treatment C | EXPERIMENTAL | Participants will receive maribavir single 200 mg commercial tablet, on Day 1 of Treatment Period 1 under fasting condition (Treatment A), followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 2 under fasting condition (Treatment B), and further followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 3 administered with a high fat/high calorie meal (Treatment C). There will be a washout period of a minimum of 72 hours between each treatment. |
| Part 1, Sequence 2: Treatment A + Treatment C + Treatment B | EXPERIMENTAL | Participants will receive maribavir single 200 mg commercial tablet, on Day 1 of Treatment Period 1 under fasting condition (Treatment A), followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 2 administered with a high fat/high calorie meal (Treatment C), and further followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 3 under fasting condition (Treatment B). There will be a washout period of a minimum of 72 hours between each treatment. |
| Part 1, Sequence 3: Treatment B + Treatment A + Treatment C | EXPERIMENTAL | Participants will receive maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 1 under fasting condition (Treatment B), followed by maribavir single 200 mg commercial tablet, on Day 1 of Treatment Period 2 under fasting condition (Treatment A), and further followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 3 administered with a high fat/high calorie meal (Treatment C). There will be a washout period of a minimum of 72 hours between each treatment. |
| Part 1, Sequence 4: Treatment B + Treatment C + Treatment A | EXPERIMENTAL | Participants will receive maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 1 under fasting condition (Treatment B), followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 2 administered with a high fat/high calorie meal (Treatment C), and further followed by maribavir single 200 mg commercial tablet, on Day 1 of Treatment Period 3 under fasting condition (Treatment A). There will be a washout period of a minimum of 72 hours between each treatment. |
| Part 1, Sequence 5: Treatment C + Treatment A + Treatment B | EXPERIMENTAL | Participants will receive maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 1 administered with a high fat/high calorie meal (Treatment C), followed by maribavir single 200 mg commercial tablet, on Day 1 of Treatment Period 2 under fasting condition (Treatment A), and further followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 3 under fasting condition (Treatment B). There will be a washout period of a minimum of 72 hours between each treatment. |
| Part 1, Sequence 6: Treatment C + Treatment B+ Treatment A | EXPERIMENTAL | Participants will receive maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 1 administered with a high fat/high calorie meal (Treatment C), followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 2 under fasting condition (Treatment B), and further followed by maribavir single 200 mg commercial tablet, on Day 1 of Treatment Period 3 under fasting condition as (Treatment A). There will be a washout period of a minimum of 72 hours between each treatment. |
| Part 2: Treatment D: maribavir 200 mg | EXPERIMENTAL | Participants will receive maribavir 200 mg pediatric powder-for-oral suspension, single oral dose on Day 1 of Treatment Period 1 under fasting condition (Treatment D). |
| Part 2, Treatment E: rabeprazole 20 mg + maribavir 200 mg | EXPERIMENTAL | Participants will receive rabeprazole single 20 mg tablet, once daily on Days 1 to 5 of Treatment Period 2 under fasting condition followed by maribavir 200 mg pediatric powder-for-oral suspension, single oral dose, 2 hours after rabeprazole dosing on morning of Day 5 of Treatment Period 2 under fasting condition (Treatment E). There will be a washout period of a minimum of 72 hours between maribavir dosing in Treatment Period 1 and first dose of rabeprazole in Treatment Period 2. |
| Name | Type | Description |
|---|---|---|
| Maribavir Commercial Tablet Formulation | DRUG | Maribavir commercial tablet. |
| Maribavir Pediatric Powder-for-oral Suspension Formulation | DRUG | Maribavir pediatric powder-for-oral suspension. |
| Rabeprazole | DRUG | Rabeprazole tablet. |
Inclusion Criteria: * An understanding, ability, and willingness to fully comply with study procedures and restrictions and to voluntarily sign (personally or via a legally authorized representative) informed consent form to participate in the study. * Age 18 to 55 years, inclusive at the time of c...
Maribavir Commercial Formulation is a small molecule drug candidate developed by Takeda Pharmaceutical Company Limited. It is also known as the Maribavir Commercial Tablet Formulation. It has been studied in a Phase 1 clinical trial in healthy adult participants.
Maribavir Commercial Formulation is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical program for this formulation.
Maribavir Commercial Formulation is in Phase 1 clinical development. It is an investigational formulation and has not been approved by the FDA. The Phase 1 trial has been completed.
Maribavir Commercial Formulation has been evaluated in one clinical trial: NCT05918822, titled A Study of Maribavir Pediatric Formulation in Healthy Adult Participants. This Phase 1 trial was completed and enrolled 32 healthy adult participants in the United States.
Yes, Maribavir Commercial Formulation is also known as the Maribavir Commercial Tablet Formulation. Both names refer to the same small molecule drug candidate developed by Takeda Pharmaceutical Company Limited.