PK/PD suppository study of NRL001 in healthy elderly subjects

• Research type

  Research Study

• Full title

  A double-blind, randomised, placebo-controlled study in elderly subjects to evaluate the safety, tolerability, pharmacodynamic effects and pharmacokinetics of a single rectal application of 10 mg NRL001 in a 2 g suppository.

• IRAS ID

  43052

• Contact name

  David J A Bell

• Sponsor organisation

  Norgine Ltd

• Eudract number

  2009-017475-16

• Research summary

  The drug being tested is in a suppository form. It is intended to treat a problem largely occurring in older people where the anal sphincter becomes incompetent leading to the leaking of faeces. This drug restores function by tightening the anal sphincter reducing the problem and improving quality of life. If large amounts of the drug get into the body then it can affect blood Pressure and pulse rate. The aim of the programme is to develop a drug which will tighten the anal sphincter and at the same time have minimal effect on the heart rate and pulse. It is hoped rectal delivery of the drug in a suppository form should combine local benefits and minimise unwanted systemic effects on the body. Previous studies of the same drug and via rectal suppository have been completed in healthy young male & female volunteers. A variety of single dose studies have been conducted which have demonstrated to a minor degree, lowering of the heart rate at higher doses.

• REC name

  HSC REC B

• REC reference

  10/NIR03/4

• Date of REC Opinion

  1 Feb 2010

• REC opinion

  Further Information Favourable Opinion