PK PD Suppository Study of NRL001

• Research type

  Research Study

• Full title

  A Randomised, Placebo-Controlled, Double-Blind, Dose Escalation Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Doses of Rectal Suppositories Containing Between 5 amd 15mg NRL001 or Matching Placebo for Two Different Sized Suppositories (1 g and 2 g)

• IRAS ID

  13582

• Sponsor organisation

  Norgine Ltd

• Eudract number

  2008-007937-27

• 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 program 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.

• REC name

  HSC REC B

• REC reference

  09/NIR03/2

• Date of REC Opinion

  3 Feb 2009

• REC opinion

  Further Information Favourable Opinion