Study of Hyoscine and Physostigmine Patch in Heathy Males and Females

• Research type

  Research Study

• Full title

  A Double-blind Investigation of the Effects of Daily Applications of the Physostigmine and Hyoscine Transdermal Patch (F11/21) with an Armband on the Pharmacokinetic (PK), Pharmacodynamic (PD) and Safety Profiles over a 21 day Period in Healthy Male and Female Caucasian Subjects.

• IRAS ID

  13687

• Sponsor organisation

  Dstl

• Eudract number

  2008-005286-58

• ISRCTN Number

  1

• Research summary

  Physostigmine has been used in the treatment of glaucoma and the poisonous effects of drugs such as tricyclic antidepressants. Hyoscine is commonly used for the treatment of motion sickness. It has been determined in animal studies that the combination of Physostigmine and Hyoscine is effective in the treatment of nerve agent poisoning and the safety and tolerability of the patch formulation has been tested in numerous human studies. It is hoped that the patch design will serve as a more convenient method of administration and remain in the blood for longer than the current treatment of pyridostigmine bromide tablets. This study will be performed at Simbec Research Limited under full medical supervision and will be funded by Dstl. Subjects will be expected to visit Simbec up to 5/6 times: the first for screening (2 days), then in house for 23 days (up to 2 visits if subjects go home after day -1), and then for their post study visit (2 days).The aim of this study is to compare the safety and the concentration of physostigmine/hyoscine in the blood after single and multiple doses in 48-54 healthy, male and female subjects. The study will also assess how the physostigmine / hyoscine patch affects the activity of an enzyme called Acetylcholinesterase (AChE). This enzyme occurs naturally in the body. This will give an indication of whether the patch may be effective against nerve agent poisoning. The patch will be applied to the skin and the drugs will be absorbed across the skin into the bloodstream (??transdermally?). The study will also assess the effect of daily applications of the F11/21 patch on eye function over a 21 day period.This study will be a double blind (the investigator and the subject will not be aware which treatments are being admininstered), randomised, (treatments will be assigned like flipping a coin), study of 48-54 healthy male and female subjects (18-40 years of age).

• REC name

  Wales REC 1

• REC reference

  09/WSE04/2

• Date of REC Opinion

  27 Jan 2009

• REC opinion

  Further Information Favourable Opinion