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Sumatriptan

Phase 1

Healthy Volunteers | Small molecule | Other |Pfizer, Inc.|Last Updated: Sep 3, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04355845A STUDY TO EVALUATE THE EFFECT OF PF-06651600 ON PHARMACOKINETICS OF SINGLE DOSE SUMATRIPTAN IN HEALTHY PARTICIPANTS.PHASE1 COMPLETED 10 — — Jun 15, 2020Aug 10, 2020Sep 3, 20201 United States
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Study Endpoints
Primary Endpoints
Sumatriptan area under the curve (AUC) extrapolated to infinite time.
Predose, at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post sumatriptan dose.
Sumatriptan (Cmax) maximum plasma concentration
Predose, at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post sumatriptan dose.
Sumatriptan AUC last PK sample.
Predose, at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post sumatriptan dose.
Secondary Endpoints
Number of participants with significant changes from baseline in vital signs.
Baseline through Period 3 Day 4 (Day 8).
Number of participants with significant changes from baseline in electrocardiogram (ECG).
Baseline through Period 3 Day 4 (Day 8).
Number of participants with significant changes from baseline in lab tests.
Baseline through Period 3 Day 4 (Day 8).
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Sumatriptan and PF-06651600 DDIEXPERIMENTALIn Period 1, participants will receive a single oral 25 mg dose of sumatriptan on Day 1 in the morning. In Period 2 on Day 1, participants will receive a single oral 25 mg dose of sumatriptan and a single 400 mg oral dose of PF-06651600 in the morning. In Period 3 participants will receive a single 400 mg oral dose of PF-06651600 in the evening of Day 1, and then a single oral 25 mg dose of sumatriptan in the morning of Day 2.
Interventions
NameTypeDescription
SumatriptanDRUG25 milligrams (mg) single dose tablet
PF-06651600DRUGPF-06651600 400 mg single dose
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male and/or female participants who are healthy as determined by medical evaluation including medical history, full physical examination which includes BP and pulse rate measurements, clinical laboratory tests, and 12-lead ECG. * BMI of 17.5 to 30.5 kg/m2; and a total body wei...

Countries:United States
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