First-time-in-human study on a new anti-hypertensive drug

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled, first-time-in-human study to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of MT-3995 in healthy male subjects; and the effect of food, gender, age and race on the pharmacokinetics of a single dose of MT-3995 in healthy subjects

• IRAS ID

  48890

• Contact name

  John Lambert

• Sponsor organisation

  Mitsubishi Pharma Europe Ltd (MPE)

• Eudract number

  2009-014884-38

• Research summary

  Hypertension is one of the world??s most prevalent chronic diseases affecting more than 60% of all people aged 60 years or older. The drug under investigation (MT-3995) appears to have a good efficacy and safety profile, based on the non-clinical studies performed, indicating that it may provide several advantages over the existing treatments in this class of anti-hypertensive drugs. In this study, MT-3995 will be administered for the first time in humans, and safety, tolerability, plasma concentrations and the effects of MT-3995 will be investigated. The effect of food, gender, age and race on the plasma concentrations of MT-3995 will also be studied. The study will be performed in different parts, and in total approximately 124 subjects are planned to be included. Healthy subjects will be included in all parts, while certain criteria regarding gender, age and race of subjects will be applied in some of the parts in order to reach valid conclusions for the study objectives. The study will be performed at the PAREXEL Early Phase Clinical Unit, Northwick Park Hospital, Harrow. The study drug will be administered to subjects in the form of a capsule(s) which they will need to swallow with water. 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, heart rate and body temperature measurements will be taken, different kinds of urine and blood safety tests will be performed, blood and urine samples for measurement of the concentration of study drug and also 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

  10/IEC06/2

• Date of REC Opinion

  20 Apr 2010

• REC opinion

  Favourable Opinion