07.Dec.2012

OCT granted Phase I Clinical Study in Dyslipidemia

OCT has recently been awarded with a Phase I clinical study in Dyslipidemia for one of the leading US Biotechnology Companies. This clinical trial is designed to investigate the safety and efficacy of the study drug in healthy volunteers.

Dyslipidemia is a disorder of lipoprotein metabolism. Lipids or fats accompanied with proteins and carbohydrates are the main components of living cells. Triglycerides and Cholesterol are lipids that are stored in the body and serve as a very important source of energy. Cholesterol also comes in two different forms known as low-density lipoproteins or (LDL) which is also referred to as bad cholesterol, and there are high-density lipoproteins or (HDL) which are also known good cholesterol. There are certain levels of each of these components which should be in the body at all times, depending on the state of health a person is in sometimes these levels can be lower or higher. When lipids levels in the bloodstream are too high or low this condition is called Dyslipidemia. The most common lipid disorder is hyperlipidemia, which are high levels blood fat.

OCT has recently been awarded with a Phase I clinical study in Dyslipidemia for one of the leading US Biotechnology Companies. This clinical trial is designed to investigate the safety and efficacy of the study drug in healthy volunteers. The trial will be fully operated and serviced by OCT from the volunteer selection process to the close out of the sites themselves. In this clinical trial OCT has decided that two sites will be sufficient in order to meet the timelines set forth by the Sponsor. The sites which will be selected for this clinical study will be operated and managed in Russia. The population for this clinical trial has been set forth as follows, 47 were screened and from that amount 40 healthy volunteers were selected. In this Phase I clinical study the study drug will be administered to the healthy volunteers in a single ascending dose. Some of the healthy volunteers who were selected and likewise others who were not was solely based on the inclusion/exclusion criteria set forth for this clinical trial. One of the main criteria for this trial was based on the healthy volunteer’s low-density lipoproteins cholesterol (LDL) in order to see if they qualified in the category of Dyslipidemia.

OCT is very pleased to have been given the opportunity to run this clinical trial for this Sponsor. OCT has good quality experience in this therapeutic area, which is one of the multiple reasons why we were selected to coordinate this clinical trial for this US Biotechnology Sponsor. OCT has a very solid background in this area of clinical studies performing studies in Atrial fibrillation, Coronary artery disease, Acute Heart Failure, and Arterial Hypertension. OCT hopes that this will be the first of many clinical studies that this Sponsor choses OCT for, and that we can develop a long progressive relationship through these operations.