A Phase I, Single-center, Randomized, Open-label, Crossover Study to Compare the White (Current Phase II) and Blue (Planned Phase III) Capsule Formulations of AZD6244 Hyd-Sulfate in Healthy Male Subjects (AZD6244Formula)

NCT01635023 Phase 1 COMPLETED

Study in Healthy Males to Compare the White and Blue Formulations of AZD6244.

Details

Lead sponsor	AstraZeneca
Phase	Phase 1
Status	COMPLETED
Enrolment	27
Start date	2012-07
Completion	2012-10

Conditions

• Healthy Volunteers

Interventions

• AZD6244 Dosing Period 1
• AZD6244 Dosing Period 2
• AZD6244 Dosing Period 3
• AZD6244 Dosing Period 4

Primary outcomes

• 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

Countries

United States