S38093 in healthy young male Japanese subjects

• Research type

  Research Study

• Full title

  Tolerability and pharmacokinetics after single and repeated oral administration of S 38093 in healthy young male Japanese subjects. A monocenter, double blind, placebo controlled, randomized phase I study (with an open part for the poor CYP 2C19 metabolizers).

• IRAS ID

  57236

• Contact name

  Daryl Bendel

• Sponsor organisation

  Servier Research and Development Ltd

• Eudract number

  2009-011500-30

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  S 38093 is an Antagonist of histamine H3 type receptors, and is being developed for the treatment of patients with mild to moderate Alzheimer's Disease (AD).The current drugs on the market for patients with mild to moderate AD are AChEI (Acetylcholinstermse Inhibitors), which show a limited treatment response. S 38093 represents a novel Mechanism of action, leading to the release of both histamine and acetylcholine, via pre-synaptic H3 receptors. This study will be conducted in Japanese male subjects and will be in 3 parts: Part 1: Double-blind, randomized, placebo-controlled, sequential design for increasing single doses. n=24 (3 groups of 8 subjects each). Part 2: Open labelled, not placebo controlled. n=6. Part 3: Double-blind, randomized, placebo-controlled, sequential design - multiple dosing. n=8.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  10/H0717/52

• Date of REC Opinion

  15 Sep 2010

• REC opinion

  Further Information Favourable Opinion