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The purpose of this study is to evaluate the multiple-dose pharmacokinetic characteristics and pharmacologic activity of gemcabene.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcabene 50 mg | Experimental | Gemcabene 50 mg |
|
| Gemcabene 150 mg | Experimental | Gemcabene 150 mg |
|
| Gemcabene 450 mg | Experimental | Gemcabene 450 mg |
|
| Gemcabene 750/600 mg | Experimental | Gemcabene 750/600 mg |
|
| Gemcabene 900 mg | Experimental | Gemcabene 900 mg |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcabene 50 mg | Drug | Gemcabene 50 mg once daily (QD) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics | Cmax | 29 days |
| Pharmacokinetcis | Area Under the Curve (AUC) | 29 days |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma lipid levels - percent change from baseline at Day 29 | percent change from baseline for LDL-C, apolipoprotein B (apoB), total cholesterol (TC), triglyceride (TG), very low density lipoprotein (VLDL-C), high density lipoprotein (HDL-C) | 29 days |
| Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C111024 | gemcabene |
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| Gemcabene 150 mg |
| Drug |
Gemcabene 150 mg once daily (QD) |
|
| Gemcabene 450 mg | Drug | Gemcabene 450 mg once daily (QD) |
|
| Gemcabene 750/600 mg | Drug | Gemcabene 750/600 mg once daily (QD) |
|
| Gemcabene 900 mg | Drug | Gemcabene 900 mg once daily (QD) |
|
| Placebo | Drug | Placebo once daily (QD) |
|
| 29 days |
| ECG | Clinically Significant Changes | 29 days |
| Clinical Laboratory - hematology, chemistry | Clinical Laboratory Abnormalities | 29 days |
| D009750 |
| Nutritional and Metabolic Diseases |