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This is a Phase I randomized double-blind, placebo-controlled, single centre study to assess the safety, tolerability and pharmacokinetics of AZD7325 following single ascending dose administration to healthy male Japanese volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD7325 | Drug | Capsule for oral, single dose |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerabilityThe nature and incidence of adverse events (AEs), vital signs,physical examinations,electrocardiograms (ECGs)and laboratory assessments. | During the study |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters for AZD7325 | During residential period | |
| Genetic analysis of the genes involved in the pharmacokinetics and safety and tolerability to AZD7325 treatment may be performed. Participation in the exploratory genetic study is optional for the subjects. |
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Inclusion Criteria:
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 | Glendale | California | United States | |||
| Research Site |
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| ID | Term |
|---|---|
| C576237 | 4-amino-8-(2-fluoro-6-methoxy-phenyl)-N-propylcinnoline-3-carboxamide |
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| Drug |
Placebo capsule for oral, single dose |
|
| During the study |
| Baltimore |
| Maryland |
| United States |