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Prasugrel ODT1 -

Phase 1

Healthy Volunteers | Small molecule | Other |Eli Lilly and Company|Last Updated: Nov 5, 2013

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01648790A Study of Prasugrel in Healthy ParticipantsPHASE1 COMPLETED 20 — — Jul 1, 2012Aug 1, 2012Nov 5, 20131 United States
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Study Endpoints
Primary Endpoints
Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test and Reference Formulation
Predose through 8 Hours Post Dose

Cmax= maximum concentration measured from predose through 8 hours postdose. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) and the reference formulation is defined as the orally disintegrating tablet without Magnasweet® (ODT1) specific to the 5 milligrams (mg) prasugrel dosing. Pharmacokinetics will measure prasugrel's (LY640315) active metabolite.

Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Reference and Test Formulation
Predose through 8 Hours Post Dose

AUC(0-tlast) = area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) and the reference formulation is defined as the orally disintegrating tablet without Magnasweet® (ODT1) specific to the 5 mg prasugrel dosing. Pharmacokinetics will measure prasugrel's active metabolite.

Secondary Endpoints
Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test Formulation in Fasted and Fed State
Predose through 8 Hours Post Dose
Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Test Formulation in Fasted and Fed State
Predose through 8 Hours Post Dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
5 mg Prasugrel (ODT1)EXPERIMENTAL5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered once in the fasted state.
5 mg Prasugrel (ODT2)EXPERIMENTAL5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered once in the fasted state.
5 mg Prasugrel (ODT2)-SuspensionEXPERIMENTAL5 mg Prasugrel as ODT2 formulation dispersed in water administered once, in the fasted state.
5 mg Prasugrel (ODT2)-FedEXPERIMENTAL5 mg Prasugrel as ODT2 formulation administered once, following a standardized breakfast.
2 mg Prasugrel (ODT2)EXPERIMENTAL2 mg Prasugrel as ODT2 formulation administered once in the fasted state.
Interventions
NameTypeDescription
Prasugrel ODT1 - TabletDRUGAdministered orally as tablet.
Prasugrel ODT2 - TabletDRUGAdministered orally as tablet.
Prasugrel ODT2 - SuspensionDRUGAdministered orally as suspension.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m\^2) Exclusion Criteria: * No known allergies to Prasugrel or related compound * No regular alcohol intake greater than 21 units per week for males or 14 units per week for females

Countries:United States
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