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This is a Phase I, single center, randomized, double-blind, placebo-controlled single ascending oral dose study to assess the safety, tolerability and pharmacokinetics of AZD7268 in healthy Japanese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD7268 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD7268 | Drug | Single Oral |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To asses the safety nature and incidence of adverse events, blood pressure, pulse rate, body temperature, physical examination, laboratory assessments (clinical chemistry, hematology, and urinalysis parameters), effects on ECG parameters, EEG recordings, | From screening period to follow-up, 44 days (maiximum). |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the pharmacokinetics of AZD7268 and its metabolite(s) in plasma and urine. | Blood and urine sampling from pre-dose until 72 hrs post dose. | |
| To collect and store DNA for future exploratory research | One blood sampling after randomisation |
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Inclusion Criteria:
Healthy Japanese male and female (of non-child bearing potential) subjects 20 to 45 years of age, inclusive
Body weight between 50 and 90 kg, inclusive, with a Body Mass Index (BMI)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Yen, MD | California Clinical Trials | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Gelndale | California | United States |
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| Drug |
Single Oral |
|