AX-8 drug safety, tolerability and plasma levels in healthy subjects.

• Research type

  Research Study

• Full title

  A Phase 1 Ascending Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of Twice Daily administration of AX-8 Tablets in Healthy Volunteers in a Single-Centre.

• IRAS ID

  262743

• Contact name

  Dave Singh

• Contact email

  dsingh@meu.org.uk

• Sponsor organisation

  Axalbion SA

• Eudract number

  2019-002294-57

• Duration of Study in the UK

  0 years, 2 months, 5 days

• Research summary

  The main purpose of the study is to see how safe the study drug, AX-8, is and how well it is tolerated when administered at different dose levels in healthy volunteers.
  
  The study will also investigate PK (pharmacokinetics i.e how the study drug is taken up, metabolised (broken down) and eliminated). AX-8, is being investigated as a potential treatment for refractory chronic cough (RCC), a cough that persists despite treatment of underlying conditions such as rhinitis and gastro-oesophageal reflux.

  AX-8 belongs to a class of drugs called “cooling compounds” (e.g. menthol, eucalyptol) which activates cold receptors and could help reduce coughing and associated symptoms in patients with RCC.

  In this study, all participants will receive the study drug in the form of a tablet that dissolves on the tongue. There is no placebo (dummy drug that doesn't contain any active ingredients).

  This study is split into four treatment periods:
  - Treatment Period 1 (2 x 5 mg tablets, 10 mg total)
  - Treatment Period 2 (2 x 10 mg tablets, 20 mg total)
  - Treatment Period 3 (2 x 20 mg tablets, 40 mg total)
  - Treatment Period 4 (2 x 40 mg tablets, 80 mg total)

  Each treatment period lasts two days and participants stay overnight in the clinic from Day 1-2. The study drug will be given only twice on Day 1 of each treatment period i.e. one tablet in the morning and the second tablet, 8 hours later.

  It is expected that a total of approximately 10 participants will take part in the study.

• REC name

  North East - York Research Ethics Committee

• REC reference

  19/NE/0211

• Date of REC Opinion

  8 Aug 2019

• REC opinion

  Favourable Opinion