Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Zavegepant non-enteric coated soft · 1 trial · 1 indication
AUCinf was calculated as AUClast+(Clast\*/kel), where AUClast is the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. AUClast was calculated using Linear/Log trapezoidal method.
Cmax was observed directly from data.
AUClast was calculated using linear/log trapezoidal method.
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | Period 1 - Single zavegepant 100mg non-enteric coated soft gel capsule (Treatment A) followed by at least 7 days washout; Period 2 - Two zavegepant 100mg immediate release tablets (Treatment C) followed by at least 7 days washout; Period 3 - Single zavegepant 100mg immediate release tablet (Treatment B) followed by at least 7 days washout; Period 4 - Four zavegepant 25mg enteric coated soft gel capsule (Treatment D). |
| Sequence 2 | EXPERIMENTAL | Period 1 - Two zavegepant 100mg immediate release tablets (Treatment C) followed by at least 7 days washout; Period 2 - Four zavegepant 25mg enteric coated soft gel capsule (Treatment D) followed by at least 7 days washout; Period 3 - Single zavegepant 100mg non-enteric coated soft gel capsule (Treatment A) followed by at least 7 days washout; Period 4 - Single zavegepant 100mg immediate release tablet (Treatment B). |
| Sequence 3 | EXPERIMENTAL | Period 1 - Single zavegepant 100mg immediate release tablet (Treatment B) followed by at least 7 days washout; Period 2 - Single zavegepant 100mg non-enteric coated soft gel capsule (Treatment A) followed by at least 7 days washout; Period 3 - Four zavegepant 25mg enteric coated soft gel capsule (Treatment D) followed by at least 7 days washout; Period 4 - Two zavegepant 100mg immediate release tablets (Treatment C). |
| Sequence 4 | EXPERIMENTAL | Period 1 - Four zavegepant 25mg enteric coated soft gel capsule (Treatment D) followed by at least 7 days washout; Period 2 - Single zavegepant 100mg immediate release tablet (Treatment B) followed by at least 7 days washout; Period 3 - Two zavegepant 100mg immediate release tablets (Treatment C) followed by at least 7 days washout; Period 4 - Single zavegepant 100mg non-enteric coated soft gel capsule (Treatment A). |
| Name | Type | Description |
|---|---|---|
| Zavegepant 100mg non-enteric coated soft gel capsule | DRUG | Zavegepant (PF-07930207/BHV3500) 100mg non-enteric coated soft gel capsule |
| Zavegepant 100mg immediate release tablet | DRUG | Zavegepant (PF-07930207/BHV3500) 100mg dodecylmaltoside dosage form immediate release tablet |
| Zavegepant 2 x 100mg immediate release tablets | DRUG | 2 x Zavegepant (PF-07930207/BHV3500) 100mg dodecylmaltoside dosage form immediate release tablets - total dose 200mg |
| Zavegepant 4 x 25mg enteric coated soft gel capsule | DRUG | Zavegepant (PF-07930207/BHV3500) 25 mg enteric coated soft gel capsules - total dose 100mg |
Inclusion Criteria: * Participants must provide Informed Consent Form (ICF) obtained prior to the conduct of any study activities. * Healthy Male or female participants at least 18 and less than 56 years of age, * Participants must be Non-smokers and not have used any nicotine-containing products f...
Zavegepant non-enteric coated soft is an investigational small molecule developed by Pfizer, Inc. (ticker: PFE). It is also known as Zavegepant 100mg non-enteric coated soft gel capsule. The drug is in Phase 1 clinical development, with one completed trial (NCT06137703) that enrolled 52 healthy volunteers to study its biological availability.
Zavegepant non-enteric coated soft targets CALCRL and RAMP1 as an antagonist. By blocking these receptors, it is designed to interfere with calcitonin gene-related peptide (CGRP) signaling. This mechanism is being explored in a Phase 1 study, but the specific indication for this formulation has not been disclosed.
Zavegepant non-enteric coated soft is developed by Pfizer, Inc., which trades under the ticker symbol PFE. Pfizer is responsible for the clinical development of this formulation.
Zavegepant non-enteric coated soft is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. One Phase 1 trial has been completed.
Zavegepant non-enteric coated soft has been studied in one completed Phase 1 trial, NCT06137703, titled "A Study to Learn About the Study Medication, Zavegepant, in Healthy Volunteers." The trial enrolled 52 healthy adult volunteers in the United States and assessed biological availability. It was randomized and controlled but not double-blind.