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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019112-21 | EudraCT Number |
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The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD7687 following multiple ascending dose administrations in in overweight to obese but otherwise healthy male subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD7687 | Drug | Oral suspension, once daily. Starting dose of 1mg and with up to 4 dose escalations. Totally 8 doses. |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety variables (adverse events, vital signs, physical examination, telemetry, digital electrocardiograms (dECGs), safety 12-lead paper electrocardiograms (pECG), and clinical laboratory assessments) | Before, during and after dosing. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Plasma and urine concentrations of AZD7687 and plasma and urine pharmacokinetic parameters | Information will be collected from the time of day -2 throughout the study. | |
| Pharmacodynamic Biomarker sampling: (Triacylglycerol in serum, triacylglycerol, diacylglycerol, insulin and free fatty acids in plasma. Triacylglycerol and diacylglycerol in adipose tissue) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Eriksson | AstraZeneca | Study Director |
| Mirjana Kucajcic | AstraZeneca | Study Chair |
| Darren Wilbraham | Quintiles, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | London | United Kingdom |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| C578442 | AZD7687 |
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| Placebo | Drug | Oral suspension, once daily. Totally 8 doses |
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| Information will be collected from the time of day -2 throughout the study. |
| Genetic: Blood sampling at one occasion during the study. | Once during study |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |