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 are orally disintegrating tablet formulations of vonoprazan being studied for administration without water or mixed with water and given via a syringe. They are being evaluated in healthy volunteers in a Phase 1 clinical trial.
The specific molecular target of Vonoprazan ODT-1 or ODT-2 without Water is not disclosed in the available information. The drug is a small molecule being studied in healthy volunteers for administration without water or mixed with water via a syringe.
Vonoprazan ODT-1 or ODT-2 without Water is being developed by Phathom Pharmaceuticals, Inc., a company traded under the ticker PHAT. The drug is currently in Phase 1 clinical development.
Vonoprazan ODT-1 or ODT-2 without Water is in Phase 1 clinical development. It is an investigational drug being studied in healthy volunteers, and it is not approved by the FDA.
Vonoprazan ODT-1 or ODT-2 without Water is being studied in a completed Phase 1 trial, NCT06831344. This trial evaluated two orally disintegrating tablet formulations administered without water or mixed with water and given via a syringe, compared to the vonoprazan tablet, in 25 healthy participants in the United States.
Vonoprazan ODT-1 or ODT-2 without Water are orally disintegrating tablet formulations of vonoprazan. They are being studied as alternative ways to administer vonoprazan, specifically without water or mixed with water and given via a syringe, relative to the standard vonoprazan tablet.