history of symptoms of grass pollen related allergic rhinitis within the previous two years MedDRA version: 9.1 Level: LLT Classification code 10001726 Term: Allergic rhinitis due to pollen
Conditions
Interventions
Product Name: OC000459
Product Code: OC000459
Pharmaceutical Form: Capsule, hard
Current Sponsor code: OC000459
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Sponsors
Oxagen Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Males aged 18 to 50 years with a history of symptoms of grass pollen related allergic rhinitis within the previous two years. 2. Subjects must be free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, neurological and psychiatric disease as determined by history, physical examination and screening investigations. 3. FEV1 within normal limits (=90% of predicted). 4. Atopy defined by a positive cutaneous response (wheal = 3mm compared to negative control) to mixed grass pollen within the last 12 months or at screening. 5. Asymptomatic at screening as characterized by: a. Normal appearing nasal mucosa with no active allergic rhinitis. b. A total nasal symptom score sheet on study entry so that subjects produce a score of =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Medical conditions likely to affect the outcome of the study. 2. Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases. 3. Presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function (defined as FEV1 = 90% predicted for height and age). 4. Immunotherapy treatment course including inhaled or local corticosteroids in the past 28 days. 5. Any infirmity, disability, or geographic location which, in the opinion of the principal investigator, would limit compliance with the protocol. 6. Infection of the upper airways/lower airways, sinus, or ear, including viral infections in the 14 days prior to screening and at the start of each treatment period. 7. Clinically significant abnormality in clinical laboratory tests at screening as determined by the principal investigator. 8. The subject has participated in a study with a new molecular entity during the previous four months or any other trial during the previous three months. 9. The subject regularly, or on average, drinks more than four units of alcohol per day. 10. A history of gastrointestinal disorder likely to influence drug absorption. 11. Receipt of prescribed or over the counter medication within 14 days of the first study day and for the duration of the trial, including vitamins and herbal remedies. 12. Inability to communicate well with the investigator (i.e., language problem, poor mental development or impaired cerebral function). 13. Donation of 450 ml or more blood within the previous 12 weeks. 14. A history of hypersensitivity and/or idiosyncrasy to any of the test compounds or excipients employed in this study. 15. Subjects known to have tuberculosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ·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.;Secondary Objective: ·To assess the safety of this treatment schedule in male subjects with allergic rhinitis. ·To assess plasma levels of OC000459 at the time of allergen challenge. ;Primary end point(s): Efficacy will be assessed as follows: Primary efficacy endpoint: Total nasal symptom score on Day 8 Secondary efficacy endpoints: Total nasal symptom score on Day 2 Individual components of total nasal symptom score, Eye symptom score, Other symptom score, secretion weight, rhinomanometry and nasal endoscopy parameters on Day 2 and Day 8 Safety will be assessed as follows: Adverse events, clinical pathology (haematology and clinical chemistry) parameters, FEV1 and vital signs. | — |
Countries
Austria
Outcome results
None listed