Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06137703 | A Study to Learn About the Study Medication, Zavegepant, in Healthy Volunteers | PHASE1 | COMPLETED | 52 | — | — | Aug 24, 2022 | Dec 7, 2022 | Oct 1, 2024 | 1 | United States |
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...