A Randomized, Open Label Study to Compare the Current Phase II and Planned Phase III Capsule Formulation of AZD6244
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | Any |
Updated: | 10/21/2012 |
Start Date: | July 2012 |
End Date: | October 2012 |
Contact: | AstraZeneca Clinial Study Information |
Email: | information.center@astrazeneca.com |
Phone: | 800-236-9933 |
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
Study in Healthy Males to Compare the White and Blue Formulations of AZD6244.
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.
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
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