AF-219 on Cough Reflex Sensitivity in Healthy + Chronic Cough Patients
Research type
Research Study
Full title
A Study to Assess the Effect of AF-219 on Cough Reflex Sensitivity in Both Healthy and Chronic Cough Subjects.
IRAS ID
177448
Contact name
Jaclyn Smith
Contact email
Sponsor organisation
Afferent Pharmaceuticals
Eudract number
2015-000464-34
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
The purpose of the study is to investigate the effect of AF-219 on cough sensitivity both in healthy subjects and subjects suffering from chronic cough. AF-219 is a P2X3 and P2X2/3 receptor antagonist (thereby blocking the action of extracellular ATP), it is the first clinical agent targeting this receptor, and is being evaluated for the treatment of chronic cough, interstitial cystitis/bladder pain syndrome and osteoarthritis pain. AF-219 may provide greater relief of symptoms and signs of these disorders, with an improved adverse event profile, compared to current treatments.
This study is a phase 2 double-blind, randomised, 4-period, crossover study in male and female healthy and chronic cough subjects. In each treatment period subjects will receive a single dose of either AF-219 300 mg or placebo administered orally. Up to 14 healthy subjects and up to 16 chronic cough subjects will be randomly assigned to one of the treatment sequences.
AF-219 is a P2X3 and P2X2/3 receptor antagonist (thereby blocking the action of extracellular ATP), throughout the study cough reflex sensitivity will be measured by standard clinical methodology incorporating capsaicin and ATP cough challenges.These cough challenges are proven methods of inducing a cough in humans and involve inhaling cough stimulating substances through the mouth. Capsaicin is an extract of chilli (hot) pepper and ATP stands for Adenosine Tri Phosphate and is found in the human body. Capsaicin and ATP will be inhaled at standard doses, which have been found to be safe and free of any serious side effects. Both of these cough challenge tests will be used to see how effective the drug is at reducing cough sensitivity. The urge-to-cough following each inhalation of challenge agent, will also be collected.
REC name
London - Fulham Research Ethics Committee
REC reference
15/LO/0470
Date of REC Opinion
1 Apr 2015
REC opinion
Further Information Favourable Opinion