Effects of Transdermal Physostigmine and Hyoscine (F11/21) on Exercise

• Research type

  Research Study

• Full title

  A Randomized, Double-blind, Placebo-controlled, Crossover Study to Investigate the Effects of Transdermal Physostigmine and Hyoscine (F11/21) on Exercise to Maximal Capacity in Healthy Male Subjects.

• IRAS ID

  41008

• Contact name

  Salvatore Febbraro

• Sponsor organisation

  DSTL

• Eudract number

  2009-016061-28

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Physostigmine has been used in the past to treat glaucoma and the poisonous effects of drugs such as tricyclic antidepressants. Hyoscine is commonly used to treat 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. A patch containing this combination has been developed to allow delivery of these drugs to the blood by wearing the patch on the skin (transdermal). This is hoped to serve as a more convenient method of drug administration than the current treatment of Pyridostigmine bromide tablets. Safety and tolerability of the patch formulation has been tested in numerous human studies involving both healthy male and female volunteers. This study is to assess the safety and tolerability of the Physostigmine-Hyoscine Patch (PHP, formally known as the NAPS2 patch) whilst subjects perform an intense exercise test. A placebo patch will also be applied to allow for comparison, this is a ??dummy-treatment? that looks identical to the PHP but contains no active ingredients. This is a double-blind (both investigator and subject will not be aware which treatments are being administered), placebo-controlled, crossover (each volunteer will receive both of the treatments) study in 8 healthy male volunteers. The study will also assess how the PHP affects activity of an enzyme which occurs naturally in the body, Acetylcholinesterase (AChE). This will give an indication of whether the patch may be effective against nerve agent poisoning. Subjects are required to attend Simbec on up to 8 occasions, up to 4 of which may be required for screening, 1 for the follow-up visit and the remaining 3 for eligibility checks prior to their transport to Dstl (the company sponsoring the research, where the exercise element and treatment periods will be performed).

• REC name

  Wales REC 1

• REC reference

  09/WSE04/70

• Date of REC Opinion

  15 Feb 2010

• REC opinion

  Further Information Favourable Opinion