Phase I/PK study of APD515

• Research type

  Research Study

• Full title

  Phase I ascending dose study of the pharmacokinetics, safety and activity of APD515 (bethanechol chloride solution for oromucosal and oral administration) in healthy volunteers

• IRAS ID

  63605

• Contact name

  Stuart Mair

• Sponsor organisation

  Acacia Pharma Ltd

• Eudract number

  2010-022146-24

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  This is a study of a well-known drug, bethanechol, reformulated for application to the inside of the mouth as a treatment for dry mouth (xerostomia). This is a common condition in the elderly and those with advanced cancer, among others, and causes discomfort, pain and dental disease. Bethanechol is known to stimulate salivary glands to produce saliva. The study will look at how safe and how active a new formulation of the drug is in healthy volunteers and how much of the drug gets into the bloodstream when it is given in three different ways: (i) to the inside of the mouth only; (ii) to the inside of the mouth, and then swallowed; (iii) swallowed only. The study, to be conducted at a unit in Nottingham specialising in such studies, is expected to last 2-3 weeks and involve about 4 healthy adult volunteers aged 50-75. The trial is sponsored by Acacia Pharma and the results will help the company in developing its new treatment for dry mouth.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  10/H0304/82

• Date of REC Opinion

  11 Nov 2010

• REC opinion

  Further Information Favourable Opinion