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Objectives:
Primary Objectives
Secondary Objectives • To determine the plasma pharmacokinetic (PK) profile of AZP-531 after single and multiple doses.
Exploratory Objectives
• To obtain exploratory data on the effects of AZP-531 on the pharmacodynamic (PD) markers of blood glucose, interstitial glucose, insulin, and plasma acylated ghrelin (AG) and unacylated ghrelin (UAG)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZP-531 | Active Comparator | subcut administration once or twice daily |
|
| Mannitol | Placebo Comparator | subcut administration once or twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZP-531 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the number of adverse events of single and multiple ascending doses AZP-531 in healthy volunteers, in overweight/obese volunteers, in patients with type 2 diabetes mellitus. | 1 to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the plasma pharmacokinetic (PK) profile of AZP-531 after single and multiple doses | 1 to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| To obtain exploratory data on the effects of AZP-531 on the pharmacodynamic (PD) markers | 1 to 14 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Ritter, MD Professor | Quintiles Drug Research Unit at Guy's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quintiles Drug Research Unit at Guy's Hospital | London | London | SE1 1YR | United Kingdom |
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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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| ID | Term |
|---|---|
| C581708 | cyclic des-acyl ghrelin (6-13) |
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|
| D004700 | Endocrine System Diseases |