Pharmacokinetics and Pharmacodynamics Study of Gemcabene in Healthy Volunteers

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

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

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