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Zavegepant non-enteric coated soft

Phase 1

Biological Availability | Small molecule | Other |Pfizer, Inc.|Last Updated: Oct 1, 2024

Target and mechanism

ModalitySmall molecule

Also known as Zavegepant 100mg non-enteric coated soft gel capsule

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

Zavegepant non-enteric coated soft · 1 trial · 1 indication

Phase 1 1
NCT06137703A Study to Learn About the Study Medication, Zavegepant, in Healthy VolunteersBiological Availability
COMPLETED52 Analytics
PHASE1COMPLETED
A Study to Learn About the Study Medication, Zavegepant, in Healthy Volunteers
Biological Availability
NCT0613770352
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Study Endpoints

Primary Endpoints

Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Zavegepant
Pre-dose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose

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.

Maximum Observed Concentration (Cmax) of Zavegepant
Pre-dose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose

Cmax was observed directly from data.

AUClast of Zavegepant
Pre-dose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose

AUClast was calculated using linear/log trapezoidal method.

Secondary Endpoints

Time to Reach Cmax (Tmax) of Zavegepant
Pre-dose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose
Terminal Phase Half-Life (t1/2) of Zavegepant
Pre-dose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose
Apparent Clearance (CL/F) of Zavegepant From Plasma
Pre-dose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Sequence 1EXPERIMENTALPeriod 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 2EXPERIMENTALPeriod 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 3EXPERIMENTALPeriod 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 4EXPERIMENTALPeriod 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).

Interventions

NameTypeDescription
Zavegepant 100mg non-enteric coated soft gel capsuleDRUGZavegepant (PF-07930207/BHV3500) 100mg non-enteric coated soft gel capsule
Zavegepant 100mg immediate release tabletDRUGZavegepant (PF-07930207/BHV3500) 100mg dodecylmaltoside dosage form immediate release tablet
Zavegepant 2 x 100mg immediate release tabletsDRUG2 x Zavegepant (PF-07930207/BHV3500) 100mg dodecylmaltoside dosage form immediate release tablets - total dose 200mg
Zavegepant 4 x 25mg enteric coated soft gel capsuleDRUGZavegepant (PF-07930207/BHV3500) 25 mg enteric coated soft gel capsules - total dose 100mg
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
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