Investigate the Safety Tolerability and Pharmacokinetics of Multiple Doses of AZD1236

Study Overview
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Brief Summary
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The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of multiple ascending oral doses of AZD1236 given to healthy young subjects for 13 days and to evaluate the single-dose relative bioavailability of the oral suspension and oral tablet formulations.

Official Title
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A Randomised Single Centre Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetics of Oral Multiple Ascending Daily Doses of AZD1236 Tablet by a Single-Blind, Placebo-Controlled, and Single Dose Relative Bioavailability of the Oral Suspension and Oral Tablet Formulations by an Open Cross-Over in Healthy Japanese Men

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: AZD1236
* Drug: Placebo
* Drug: AZD1236
* Drug: AZD1236


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed informed consent prior to any study specific procedures Body Mass Index (BMI) between 19-27 kg/m2 Exclusion Criteria: Receipt of another investigational drug in the 4 months before dosing in this study Acute illness which requires medical intervention within 2 weeks of Visit 2. Abnormal resting BP and pulse rate (after resting for 10 minutes). Supine blood pressure > 140 mmHg systolic or >90 mmHg diastolic, pulse<= 50 or => 90 beats per minute

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>AZD1236 tablet | Drug: AZD1236<br>* 75mg once daily or 75mg twice daily will be administered in multiple dose part.<br>|
| Placebo Comparator: Placebo<br>Placebo tablet | Drug: Placebo<br>* Placebo tablet matching to the active in multiple dose part.<br>|
| Other: Relative bioavailability<br>AZD1236 Oral suspension | Drug: AZD1236<br>* 75mg single dose will be administered in relative bioavailability part.<br>|
| Other: Relative bioavailability tablet<br>AZD1236 tablet | Drug: AZD1236<br>* 75mg oral suspension single dose will be administered in relative bioavailability part.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of AZD1236 by assessment of blood pressure, pulse rate, body temperature, laboratory variables, ECG and adverse events |  | Assessments taken at screening visit, defined timepoints pre-dose and post-dose during treatment periods and follow up visit. Volunteers will be monitored throughout the study for adverse events. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile: concentration of AZD1236 in blood |  | Samples taken during Visit 2 in multiple dosing part at 41 points and Visit 2/3 in relative bioavailability part at 32 points. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Volunteer, Safety, Tolerability, Pharmacokinetics, AZD1236