AZD6244Formula: A Randomized, Open Label Study to Compare the Current Phase II and Planned Phase III Capsule Formulation of AZD6244
Study Details
Study Description
Brief Summary
Study in Healthy Males to Compare the White and Blue Formulations of AZD6244.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AZD6244 white capsule 75mg AZD6244 white (current Phase II) capsule |
Drug: AZD6244 Dosing Period 1
Treatment A, B, or C depending on randomization assignment
Other Names:
Drug: AZD6244 Dosing Period 2
Treatment A, B, or C depending on randomization assignment
Other Names:
Drug: AZD6244 Dosing Period 3
Treatment A, B, or C depending on randomization assignment
Other Names:
|
| Experimental: AZD6244 blue capsule 75mg AZD6244 blue (planned Phase III) capsule |
Drug: AZD6244 Dosing Period 1
Treatment A, B, or C depending on randomization assignment
Other Names:
Drug: AZD6244 Dosing Period 2
Treatment A, B, or C depending on randomization assignment
Other Names:
Drug: AZD6244 Dosing Period 3
Treatment A, B, or C depending on randomization assignment
Other Names:
Drug: AZD6244 Dosing Period 4
Treatment B
Other Names:
|
| Experimental: AZD6244 solution 35mg AZD6244 oral solution |
Drug: AZD6244 Dosing Period 1
Treatment A, B, or C depending on randomization assignment
Other Names:
Drug: AZD6244 Dosing Period 2
Treatment A, B, or C depending on randomization assignment
Other Names:
Drug: AZD6244 Dosing Period 3
Treatment A, B, or C depending on randomization assignment
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Reseatch Site | Overland Park | Kansas | United States |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Study Director: Ian Smith, MEDICAL SCIENCE DIRECTOR, AstraZeneca
- Principal Investigator: Eleanor Lisbon, MD, Quintiles, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D1532C00066