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Eletriptan commercial

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Jan 28, 2021

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
RandomizedCONTROLLED
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01139515Eletriptan Pharmacokinetics In Korean MalesPHASE1 COMPLETED 16 — — Jul 1, 2010Jul 1, 2010Jan 28, 20211 South Korea
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Study Endpoints
Primary Endpoints
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]
Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose(D)

AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).

AUC From Time Zero to Last Quantifiable Concentration (AUClast)
Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)

Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).

Maximum Observed Plasma Concentration (Cmax)
Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)
Secondary Endpoints
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)
Plasma Decay Half Life (t1/2)
Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Treatment AEXPERIMENTAL1 X 20 mg eletriptan
Treatment BEXPERIMENTAL1 X 40 mg eletriptan
Treatment CEXPERIMENTAL2 X 40 mg eletriptan
Treatment DEXPERIMENTAL1 X 40 mg tablet given 2 hr after initial 1 X 40 mg tablet dose
Interventions
NameTypeDescription
Eletriptan commercial tabletDRUG20 mg tablet, single dose
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * healthy male subjects, 18-55 years old * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 * provide informed consent Exclusion Criteria: * blood pressure \>140/90 mm Hg * any condition possibly affecting drug absorption * positive urine drug screen

Countries:South Korea
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