A Randomized, Open Label Study to Compare the Current Phase II and Planned Phase III Capsule Formulation of AZD6244

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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

Key facts

Study ID

NCT01635023

Run by

AstraZeneca

People needed

27

Starts

2012-07-01

Expected to finish

2012-10-01

Last updated by the study team

2012-10-25

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Reseatch Site — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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