Single oral doses of MT-3395 with activated charcoal

• Research type

  Research Study

• Full title

  A phase I, single-centre, open-label study in healthy male volunteers investigating the elimination of MT-3995 in combination with activated charcoal

• IRAS ID

  76607

• Contact name

  John Lambert

• Sponsor organisation

  Mitsubishi Pharma Europe (MPE)

• Eudract number

  2011-000304-18

• 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 investigate what flunce doses of activated charcoal have on the levels of study drug in the bloodstream. Participants will receive the study drug (40 mg of MT-3995) in the form of two capsules which they swallow with a small glass (180 mL) of water. Participants will receive a suspension of 50 g of activated charcoal in 250 mL of water. After drinking the suspension, they will rinse the cup with a further 100 mL of water and then drink the water rinse. Participants 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, any adverse events that participants experience and other medication they take, will be recorded. The study will be performed at the PAREXEL Early Phase Clinical Unit, Northwick Park Hospital, Harrow, London.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  11/IE/0057

• Date of REC Opinion

  15 Apr 2011

• REC opinion

  Favourable Opinion