AZD9056 Relative Bioavailability Study

Study Overview
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Brief Summary
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The aims of this study are to compare the blood levels achieved with a new formulation of AZD9056 to an existing formulation of AZD9056 used in previous studies.

Official Title
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An Open-label, Randomized, 2 Cohort, 2 Period Crossover Study to Assess the Relative Bioavailability of the Phase III to the Phase IIb Formulation of AZD9056 in Healthy Male and Female Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: AZD9056 formulation Phase III 50 mg (T)
* Drug: AZD9056 formulation Phase IIb 50 mg (R)
* Drug: AZD9056 formulation Phase III 200 mg (T)
* Drug: AZD9056 formulation Phase IIb 200mg (R)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent prior to any study-specific procedures Healthy Volunteers, Females should not be of childbearing potential BMI between 18 and 30 kg/m2 Exclusion Criteria: Clinically significant ECG abnormality suggestive of underlying cardiovascular disease A history or presence of GI, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism and excretion of drugs Known or suspected drug or alcohol abuse or positive DOA test

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

Sexes Eligible for Study
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All

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>50 or 400 mg AZD9056, Test formulation | Drug: AZD9056 formulation Phase III 50 mg (T)<br>* Given as 50 mg tablet (T)<br>Drug: AZD9056 formulation Phase III 200 mg (T)<br>* Given as 400 mg (2 x 200 mg tablet (T))<br>|
| Experimental: 2<br>50 or 400 mg AZD9056, Reference formulation | Drug: AZD9056 formulation Phase IIb 50 mg (R)<br>* Given as 50 mg tablet (R)<br>Drug: AZD9056 formulation Phase IIb 200mg (R)<br>* Given as 400 mg (2 x 200 mg tablet (R))<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative bioavailability of AZD9056 using PK variables Cmax and AUC |  | For each study period, intensive sampling occasions on day 1: half hourly after dosing until 4 hours, then 4,6,8 and 12 hours post dose, with once daily sampling on days 2 to 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive PK parameters for AZD9056 using PK variables (tmax, AUC(0-t), t1/2, CL/F and Vz/F) |  | For each study period, intensive sampling occasions on day 1: half hourly after dosing until 4 hours, then 4,6,8 and 12 hours post dose, with once daily sampling on days 2 to 7 | 
| Safety variables (adverse events, safety lab, blood pressure, pulse, ECG) |  | Frequent sampling occasions throughout the study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relative Bioavailability, AZD9056