Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Zavegepant immediate release · 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 immediate release is an investigational small molecule being studied for biological availability. It is currently in Phase 1 clinical development and is not approved by the FDA. The drug is being developed by Pfizer, Inc.
Zavegepant immediate release is being studied for biological availability, which refers to the rate and extent to which the drug becomes available in the body. It is in Phase 1 clinical trials to evaluate this property in healthy volunteers.
Zavegepant immediate release is being developed by Pfizer, Inc., a biopharmaceutical company. The company is conducting clinical trials to study the drug's biological availability in healthy volunteers.
Zavegepant immediate release is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed to study its biological availability.
Zavegepant immediate release has one completed Phase 1 trial, NCT06137703, titled 'A Study to Learn About the Study Medication, Zavegepant, in Healthy Volunteers.' The trial enrolled 52 participants in the United States and studied biological availability.
Zavegepant immediate release is a formulation of the drug zavegepant. The immediate release version is being studied in Phase 1 trials for biological availability, while other formulations may have different characteristics.