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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: AZD6244 Dosing Period 1
* Drug: AZD6244 Dosing Period 2
* Drug: AZD6244 Dosing Period 3
* Drug: AZD6244 Dosing Period 4


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD6244 white capsule<br>75mg AZD6244 white (current Phase II) capsule | Drug: AZD6244 Dosing Period 1<br>* Treatment A, B, or C depending on randomization assignment<br>* Other names: AZD6244;Drug: AZD6244 Dosing Period 2<br>* Treatment A, B, or C depending on randomization assignment<br>* Other names: AZD6244;Drug: AZD6244 Dosing Period 3<br>* Treatment A, B, or C depending on randomization assignment<br>* Other names: AZD6244;|
| Experimental: AZD6244 blue capsule<br>75mg AZD6244 blue (planned Phase III) capsule | Drug: AZD6244 Dosing Period 1<br>* Treatment A, B, or C depending on randomization assignment<br>* Other names: AZD6244;Drug: AZD6244 Dosing Period 2<br>* Treatment A, B, or C depending on randomization assignment<br>* Other names: AZD6244;Drug: AZD6244 Dosing Period 3<br>* Treatment A, B, or C depending on randomization assignment<br>* Other names: AZD6244;Drug: AZD6244 Dosing Period 4<br>* Treatment B<br>* Other names: AZD6244;|
| Experimental: AZD6244 solution<br>35mg AZD6244 oral solution | Drug: AZD6244 Dosing Period 1<br>* Treatment A, B, or C depending on randomization assignment<br>* Other names: AZD6244;Drug: AZD6244 Dosing Period 2<br>* Treatment A, B, or C depending on randomization assignment<br>* Other names: AZD6244;Drug: AZD6244 Dosing Period 3<br>* Treatment A, B, or C depending on randomization assignment<br>* Other names: AZD6244;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase I, healthy volunteers, AZD6244, pharmacokinetics, AUC, Cmax, tmax, AUC(0-t)