Recent Updates
Recently added Catalysts

AZD6244 Dosing

Phase 1

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

Target and mechanism

ModalitySmall molecule

Also known as AZD6244 Dosing Period 1

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

AZD6244 Dosing · 1 trial · 1 indication

Phase 1 1
NCT01635023A Randomized, Open Label Study to Compare the Current Phase II and Planned Phase III Capsule Formulation of AZD6244Healthy Volunteers
COMPLETED27 Analytics
PHASE1COMPLETED
A Randomized, Open Label Study to Compare the Current Phase II and Planned Phase III Capsule Formulation of AZD6244
Healthy Volunteers
NCT0163502327
Unlock trial analytics

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
Unlock Study Endpoints

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
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 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
Unlock Eligibility Criteria