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AZD6244 Dosing Period 1

Phase 1

Healthy Volunteers | Small molecule | Other |AstraZeneca PLC|Last Updated: Oct 25, 2012

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 Enrollment27
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01635023A Randomized, Open Label Study to Compare the Current Phase II and Planned Phase III Capsule Formulation of AZD6244PHASE1 COMPLETED 27 — — Jul 1, 2012Oct 1, 2012Oct 25, 20121 United States
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Study Endpoints
Primary Endpoints
AUC for AZD6244 administered as a single dose of white (current Phase II) capsule formulation
Measured at appropriate time-points until end of treatment peiod, approximately 24 days
Cmax for AZD6244 administered as a ingle dose of white (current Phase II) capsule formulation
Measured at appropriate time-points until end of treatment peiod, approximately 24 days
AUC for AZD6244 administered as a single dose of blue (planned Phase III) capsule formulation
Measured at appropriate time-points until end of treatment peiod, approximately 24 days
Cmax for AZD6244 administered as a single dose of blue (planned Phase III) capsule formulation
Measured at appropriate time-points until end of treatment peiod, approximately 24 days
Secondary Endpoints
Frequency and severity of adverse events
Measured throughout the study and for a7 days after the last dose, approximately 29 days
AUC for AZD6244 administered as a single dose of oral solution formulation
Measured at appropriate time-points until end of treatment peiod, approximately 24 days
Cmax for AZD6244 administered as a single dose of oral solution formulation
Measured at appropriate time-points until end of treatment peiod, approximately 24 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
AZD6244 white capsuleEXPERIMENTAL75mg AZD6244 white (current Phase II) capsule
AZD6244 blue capsuleEXPERIMENTAL75mg AZD6244 blue (planned Phase III) capsule
AZD6244 solutionEXPERIMENTAL35mg AZD6244 oral solution
Interventions
NameTypeDescription
AZD6244 Dosing Period 1DRUGTreatment A, B, or C depending on randomization assignment
AZD6244 Dosing Period 2DRUGTreatment A, B, or C depending on randomization assignment
AZD6244 Dosing Period 3DRUGTreatment A, B, or C depending on randomization assignment
AZD6244 Dosing Period 4DRUGTreatment B
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male volunteers aged 18 to 55 BMI between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg, inclusive Calculated creatinine clearance (CRCL) greater than 50 mL/min usin gthe Cockcroft-Gault formula Exclusion Criteria: * History or presence o...

Countries:United States
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