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The purpose of this study is to assess safety and tolerability of AZD1656 after single ascending oral doses in Japanese healthy male subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD1656 in 6 increasing oral single doses given to 6 groups (5 on active and 1 on placebo in each group) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1656 | Drug | Dose escalation of oral single doses of AZD1656 to achieve maximal tolerated dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety variables (AEs, blood pressure (BP), pulse, safety laboratory variables and electrocardiography (ECG) | Safety variables taken repeatedly during 24 hours on study day sessions |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic variables | Pharmacokinetic variables taken repeatedly during 24 hours on study day sessions | |
| Pharmacodynamic variables | Blood samples taken repeatedly during 24 hours on study day sessions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Klas Malmberg, MD, PhD Prof | AstraZeneca R&D Mölndal | Study Director |
| Mark Yen, MD | California Clinical Trials | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Glendale | California | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22943931 | Derived | Ericsson H, Roshammar D, Wollbratt M, Heijer M, Persson M, Ueda S, Leonsson-Zachrisson M, Norjavaara E. Tolerability, pharmacokinetics, and pharmacodynamics of the glucokinase activator AZD1656, after single ascending doses in healthy subjects during euglycemic clamp. Int J Clin Pharmacol Ther. 2012 Nov;50(11):765-77. doi: 10.5414/CP201747. |
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| ID | Term |
|---|---|
| C576407 | AZD1656 |
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