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The purpose of this study is to investigate the safety and tolerability of AZD5658 following ascending single oral doses in Type 2 Diabetics. It will also estimate the maximum tolerated dose.
This is a randomized, single-blind, placebo-controlled, single-center, phase 1 study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and the effect of fasting after single ascending oral doses of AZD5658 in type 2 diabetes mellitus patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6 - 8 cohorts | Experimental | 6 patients in each cohort will receive AZD5658 |
|
| 6 - 8 cohorts | Placebo Comparator | 2 patients in each cohort will receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD5658 | Drug | oral suspension, escalating single doses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the safety and tolerability of AZD5658 following oral administration of single ascending doses and to estimate the maximum tolerated dose (MTD). | AEs-, blood pressure and pulse during study days. Safety labs - day -1 to day 4; ECG - days 1, 2 and 3 |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the pharmacokinetics of AZD5658 after single ascending oral doses in type 2 diabetes mellitus patients. | Venous blood samples for the determination of concentrations of AZD5658 in plasma will be taken predose and at various times up to 72 hours postdose | |
| Pharmacodynamics (plasma glucose and serum insulin) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karin Wahlander | AstraZeneca R&DPepparedsleden 1431 83 M�lnda | Study Director |
| Mirjana Kujacic | AstraZeneca R&DPepparedsleden 1431 83 M�lndal | Study Chair |
| Linda Morrow | Profil Institute for Clinical Research, Inc.855 Third Avenue, Suite 4400Chula Vista, CA 91911 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Chula Vista | California | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo |
| Drug |
oral suspension,single doses |
|
| Plasma glucose and serum insulin determined on Day -1 through Day 4 |
| Effect of fasting on the pharmacokinetics and explore the pharmacodynamics of AZD5658. |
| D004700 | Endocrine System Diseases |