Pharmacokinetics and Pharmacodynamics Study of Gemcabene in Healthy Volunteers

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the multiple-dose pharmacokinetic characteristics and pharmacologic activity of gemcabene.

Official Title
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An Oral, Rising, Multiple-Dose Tolerance, Pharmacokinetic and Pharmacodynamic Study of Gemcabene Capsules in Healthy Volunteers

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: Gemcabene 50 mg
* Drug: Gemcabene 150 mg
* Drug: Gemcabene 450 mg
* Drug: Gemcabene 750/600 mg
* Drug: Gemcabene 900 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Good health as determined by medical history, physical examination, electrocardiogram (ECG), vital signs, and laboratory assessments Body weight: 60-100 kg (desirable) Exclusion Criteria: Use of any medication not considered acceptable by the clinical investigators during the 14-day period before the start of the study (Day 1) ; Donation of a unit of blood or participation in a study of investigational or marketed drugs during the 30-day period before the start of the study (Day 1); If female, of childbearing potential or lactating; History of significant reaction to any fibrate lipid-lowering agent; and Significant urine collection of any drug which could interfere with the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemcabene 50 mg<br>Gemcabene 50 mg | Drug: Gemcabene 50 mg<br>* Gemcabene 50 mg once daily (QD)<br>|
| Experimental: Gemcabene 150 mg<br>Gemcabene 150 mg | Drug: Gemcabene 150 mg<br>* Gemcabene 150 mg once daily (QD)<br>|
| Experimental: Gemcabene 450 mg<br>Gemcabene 450 mg | Drug: Gemcabene 450 mg<br>* Gemcabene 450 mg once daily (QD)<br>|
| Experimental: Gemcabene 750/600 mg<br>Gemcabene 750/600 mg | Drug: Gemcabene 750/600 mg<br>* Gemcabene 750/600 mg once daily (QD)<br>|
| Experimental: Gemcabene 900 mg<br>Gemcabene 900 mg | Drug: Gemcabene 900 mg<br>* Gemcabene 900 mg once daily (QD)<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo once daily (QD)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics | Cmax | 29 days | 
| Pharmacokinetcis | Area Under the Curve (AUC) | 29 days | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 29 days | 
| ECG | Clinically Significant Changes | 29 days | 
| Clinical Laboratory - hematology, chemistry | Clinical Laboratory Abnormalities | 29 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Lipid Regulator