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This phase I study will evaluate safety and tolerability after repeated doses of AZD0837.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Low dose |
|
| 2 | Experimental | Middle dose |
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| 3 | Experimental | High dose |
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| 4 | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD0837 | Drug | tablet, oral, once daily, 1+5 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the safety and tolerability of AZD0837 after single and repeated oral dosing of AZD0837 extended release (ER) tablet, in Japanese healthy subjects. | All assessments are made at each visit, at least daily, during the study. |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the pharmacokinetics (PK) of AZD0837, AR H069927XX and AR-H067637XX after single and repeated oral dosing of AZD0837 ER tablet, in Japanese healthy subjects. | Blood samples will be taken before and after study drug administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hiroyuki Fukase, MD, PhD | CPC Clinic, Medipolis Medical Research Institute, Kagoshima, Japan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Kagoshima | Japan |
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| ID | Term |
|---|---|
| C551586 | AZD 0837 |
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| Placebo |
| Drug |
Placebo |
|