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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

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Conditions:		Healthy Volunteers
Purpose:		Study in Healthy Males to Compare the White and Blue Formulations of AZD6244.
Study Summary:		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.
Criteria:		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 of gastrointestinal, hepatic, or renal disease or any other condition know to interfere with absorption, distribution, metabolism, or exertion of drugs. - Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, or HIV. - Any clinically important abnormalities in rhythm, conduction, or morphology of the resting dECG and any clinically important abnormalities in the 12-lead dECG that suggest a cardiac, metabolic or other noncardiac condition. - Current or past history of central serous retinopathy or retinal vein thrombosis, intraocular pressure greater than 21 mmHg or uncontrolled glaucoma Known or suspected history of drug abuse, current smokes or those who have smoked or used nicotine-containing products within the previous 3 months
NCT ID:		NCT01635023
Primary Contact:		Study Director Ian Smith, MEDICAL SCIENCE DIRECTOR AstraZeneca
Backup Contact:		N/A
Location Contact:		Overland Park, Kansas United States There is no listed contact information for this specific location. Site Status: N/A

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