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The Purpose of this study is to determine the safety and tolerability of 1-MNA, a drug that is intended to be used in the treatment of elevated levels of blood fats. This study will determine the way that 1-MNA is handled by the body, and will also determine its effect on commonly measured blood fat parameters.
Dyslipidemia is a major risk factor for coronary artery disease (CAD) and its management is important in preventing the occurrence of cardiovascular events. Dyslipidemia occurs when there is an imbalance in the metabolism and clearance of lipoproteins resulting in lipoprotein overproduction or deficiency. Lipid related risk factors for atherosclerotic coronary artery disease include elevated levels of total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), intermediate-density lipoprotein cholesterol (IDL-C), very low-density lipoprotein cholesterol (VLDL-C) and reduced concentrations of high-density lipoprotein cholesterol (HDL-C). This lipid risk profile frequently occurs in association with other cardiovascular risk factors (e.g., obesity, elevated blood pressure, diabetes mellitus), and is associated with premature atherosclerosis (NCEP, 2002).
The Main purpose of this study is to formally evaluate the safety and pharmacokinetics and pharmacodynamics of 1-MNA, a hypolipidemic agent with previous human exposure in normal subjects and patients with Hyperlipidemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 1-MNA-Low Dose |
|
| 2 | Active Comparator | 1-MNA-High Dose |
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| 3 | Placebo Comparator | Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1-MNA | Drug | Capsule |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The single dose pharmacokinetics and safety of 1-MNA and an assessment of any gender-based differences in plasma pharmacokinetics | Over 24 hours following a dose |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of 1-MNA on triglycerides and lipase activity and lipid profiles after single oral dosages | Over 24 hours following a single dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles H Ballow, Pharm D. | Buffalo Clinical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buffalo Clinical Research Center | Buffalo | New York | 14202 | United States |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Drug |
Capsule |
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|