The study will assess the efficacy of OC000459 200 mg twice daily orally in comparison to placebo when subjects are challenged in the Vienna Challenge Chamber for 6 hours. This is a randomised, double blind, placebo controlled, two way crossover evaluation. There will be a screening period of up to three weeks and a washout period of at least one week between the two treatment periods. There will be a follow up one to three weeks after the last dose of study drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
Vienna Challenge Chamber
Vienna, Austria
Efficacy of OC00045 on response to allergen challenge as measured by change in Total Nasal Symptom Score
To assess the efficacy of OC000459 200 mg twice daily orally in comparison to placebo when subjects are challenged in the Vienna Challenge Chamber for 6 hours as shown by the effect on Total Nasal Symptom Score
Time frame: 8 days
OC000459 safety as determined by adverse events, laboratory parameters, lung function and vital signs
To assess the safety of this treatment schedule in male subjects with allergic rhinitis as assessed via adverse events, clinical chemistry and haematology, FEV1 and vital signs.
Time frame: 8 days
OC000459 plasma concentration (Cmin)
To assess plasma levels of OC000459 at the time of allergen challenge (trough plasma level).
Time frame: 8 days
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