Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vonoprazan ODT-1 or ODT-2 without Water · 1 trial · 1 indication
Cmax of Vonoprazan was reported.
AUC0-t of Vonoprazan was reported.
AUC0-inf of Vonoprazan was reported.
| Arm | Type | Description |
|---|---|---|
| Sequence A, B, C, D, E: Vonoprazan 10 mg | EXPERIMENTAL | Participants will be randomly assigned to 1 of 5 treatment sequences in a 1:1:1:1:1 ratio. On the first day of each dosing period, participants will receive 1 of the following study treatments according to the treatment sequence they are randomly assigned to: * Treatment A: Vonoprazan 10 mg ODT-1 without water * Treatment B: Vonoprazan 10 mg ODT-1 mixed with water and administered via a syringe * Treatment C: Vonoprazan 10 mg ODT-2 without water * Treatment D: Vonoprazan 10 mg ODT-2 mixed with water and administered via a syringe * Treatment E (reference): Vonoprazan 10 mg tablet. There will be a washout interval of a minimum of 5 days between study drug dosing in each period. |
| Sequence B, D, E, C, A: Vonoprazan 10 mg | EXPERIMENTAL | Participants will be randomly assigned to 1 of 5 treatment sequences in a 1:1:1:1:1 ratio. On the first day of each dosing period, participants will receive 1 of the following study treatments according to the treatment sequence they are randomly assigned to: * Treatment A: Vonoprazan 10 mg ODT-1 without water * Treatment B: Vonoprazan 10 mg ODT-1 mixed with water and administered via a syringe * Treatment C: Vonoprazan 10 mg ODT-2 without water * Treatment D: Vonoprazan 10 mg ODT-2 mixed with water and administered via a syringe * Treatment E (reference): Vonoprazan 10 mg tablet. There will be a washout interval of a minimum of 5 days between study drug dosing in each period. |
| Sequence C, E, B, A, D: Vonoprazan 10 mg | EXPERIMENTAL | Participants will be randomly assigned to 1 of 5 treatment sequences in a 1:1:1:1:1 ratio. On the first day of each dosing period, participants will receive 1 of the following study treatments according to the treatment sequence they are randomly assigned to: * Treatment A: Vonoprazan 10 mg ODT-1 without water * Treatment B: Vonoprazan 10 mg ODT-1 mixed with water and administered via a syringe * Treatment C: Vonoprazan 10 mg ODT-2 without water * Treatment D: Vonoprazan 10 mg ODT-2 mixed with water and administered via a syringe * Treatment E (reference): Vonoprazan 10 mg tablet. There will be a washout interval of a minimum of 5 days between study drug dosing in each period. |
| Sequence D, C, A, E, B: Vonoprazan 10 mg | EXPERIMENTAL | Participants will be randomly assigned to 1 of 5 treatment sequences in a 1:1:1:1:1 ratio. On the first day of each dosing period, participants will receive 1 of the following study treatments according to the treatment sequence they are randomly assigned to: * Treatment A: Vonoprazan 10 mg ODT-1 without water * Treatment B: Vonoprazan 10 mg ODT-1 mixed with water and administered via a syringe * Treatment C: Vonoprazan 10 mg ODT-2 without water * Treatment D: Vonoprazan 10 mg ODT-2 mixed with water and administered via a syringe * Treatment E (reference): Vonoprazan 10 mg tablet. There will be a washout interval of a minimum of 5 days between study drug dosing in each period. |
| Sequence E, A, D, B, C: Vonoprazan 10 mg | EXPERIMENTAL | Participants will be randomly assigned to 1 of 5 treatment sequences in a 1:1:1:1:1 ratio. On the first day of each dosing period, participants will receive 1 of the following study treatments according to the treatment sequence they are randomly assigned to: * Treatment A: Vonoprazan 10 mg ODT-1 without water * Treatment B: Vonoprazan 10 mg ODT-1 mixed with water and administered via a syringe * Treatment C: Vonoprazan 10 mg ODT-2 without water * Treatment D: Vonoprazan 10 mg ODT-2 mixed with water and administered via a syringe * Treatment E (reference): Vonoprazan 10 mg tablet. There will be a washout interval of a minimum of 5 days between study drug dosing in each period. |
| Name | Type | Description |
|---|---|---|
| Vonoprazan ODT-1 or ODT-2 without Water | DRUG | Vonoprazan will be administered orally as an ODT-1 or ODT-2 without water |
| Vonoprazan ODT-1 or ODT-2 with Water | DRUG | Vonoprazan will be administered orally as an ODT-1 or ODT-2 with water via a syringe |
| Vonoprazan (Reference) | DRUG | Vonoprazan will be administered orally as a tablet |
Inclusion Criteria: * The participant is 18 to 55 years of age, inclusive, at Screening. * The participant has a body mass index (BMI) 18 to 32 kg/m2, inclusive, at Screening. * The participant is considered by the investigator to be in good general health as determined by medical history, clinical...
Vonoprazan ODT-1 or ODT-2 without Water refers to two orally disintegrating tablet formulations of vonoprazan that are designed to be taken without water. Vonoprazan is a small molecule drug being developed by Phathom Pharmaceuticals, Inc. (ticker: PHAT). These specific formulations are investigational and have been studied in a Phase 1 clinical trial.
Vonoprazan ODT-1 or ODT-2 without Water targets the ATP4A and ATP4B subunits of the gastric proton pump. It acts as an inhibitor of these targets. By inhibiting ATP4A and ATP4B, vonoprazan suppresses gastric acid secretion.
Vonoprazan ODT-1 or ODT-2 without Water is being developed by Phathom Pharmaceuticals, Inc., which trades under the ticker symbol PHAT. Phathom Pharmaceuticals is the sponsor of the clinical trial evaluating these formulations.
Vonoprazan ODT-1 or ODT-2 without Water is in Phase 1 clinical development. The Phase 1 trial has been completed. The drug is investigational and has not been approved by the FDA for any indication.
Vonoprazan ODT-1 or ODT-2 without Water has been evaluated in a single Phase 1 clinical trial, NCT06831344. The trial was titled "A Study to Evaluate Two Vonoprazan Orally Disintegrating Tablet Formulations Administered Without Water or Mixed With Water and Administered Via a Syringe Relative to the Vonoprazan Tablet in Healthy Participants." It enrolled 25 healthy volunteers in the United States and has been completed.