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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | AZD1236 tablet |
|
| Placebo | Placebo Comparator | Placebo tablet |
|
| Relative bioavailability | Other | AZD1236 Oral suspension |
|
| Relative bioavailability tablet | Other | AZD1236 tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1236 | Drug | 75mg once daily or 75mg twice daily will be administered in multiple dose part. |
| |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shunji Matsuki, MD PhD | Kyushu Clinical Pharmacology Research Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Osaka | Osaka | Japan |
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| ID | Term |
|---|---|
| C000713527 | 4-((5-chloro-2-pyridinyl)oxy)-1-((((4S)-4-methyl-2,5-dioxo-4-imidazolidinyl)methyl)sulfonyl)-piperidine |
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| Placebo |
| Drug |
Placebo tablet matching to the active in multiple dose part. |
|
| AZD1236 | Drug | 75mg single dose will be administered in relative bioavailability part. |
|
| AZD1236 | Drug | 75mg oral suspension single dose will be administered in relative bioavailability part. |
|