Single oral doses of MT-3995 with fludrocortisone challenge

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled study to evaluate the pharmacodynamic effects of single oral doses of MT-3995 in healthy subjects, after fludrocortisone challenge, using eplerenone as an active control

• IRAS ID

  70979

• Contact name

  John Lambert

• Sponsor organisation

  Mitsubishi Pharma Europe (MPE)

• Eudract number

  2010-021830-79

• Research summary

  This study is being carried out to investigate a compound called MT-3995 which is being developed for treating high blood pressure. High blood pressure (hypertension) is usually defined as having a sustained blood pressure of 140/90 mmHg or above. High blood pressure often causes no symptoms or immediate problems, but it is a major risk factor for developing a serious cardiovascular disease, such as a stroke or heart disease. The main purpose of the study is to see what effect the study drug has on the body when it is taken after taking a medication already on the market calleflurocortisoneflurocortisone is used as replacement therapy. Its action in the body is similar to the naturally produced steroid hormone aldosterone (which regulates the amounts of electrolytes in the body). The study will also see how safe the study drug is and how well it is tolerated after dosing, and further investigate how the study drug is taken up, metabolised (broken down) and distributed through the body. This study will also compare the study drug to a similar product already on the market, namely eplerenone. This medication is used alone or in combination with other medicines to treat heart failure in the UK as well as high blood pressure in the United States of America and Japan.Subjects will undergo the following procedures during the study: medical history and demographic data will be collected, physical examinations and electrocardiograms (ECGs) will be performed, height and weight will be measured, blood pressure, pulse rate and body temperature measurements will be taken, different kinds of urine and blood safety tests will be performed, blood samples for measurement of the concentration of study drug and urine samples for measurement of some of the effects of the study drug will be taken, any adverse events that subjects experience and other medication they take, will be recorded.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  11/IE/0033

• Date of REC Opinion

  29 Mar 2011

• REC opinion

  Further Information Favourable Opinion