Allergen Challenge Chamber Study With Single Dose Oral GSK835726 Compared With Placebo

Study Overview
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Brief Summary
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A randomised, double-blind, placebo-controlled, 4-period incomplete block crossover study of single oral dose GSK835726 (100mg, 50mg, 10mg), Cetirizine (10mg) and placebo to evaluate the efficacy and safety using an Environmental challenge chamber in male subjects with seasonal allergic rhinitis

Official Title
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A Randomised, Double-blind, Placebo-controlled, 4-period Incomplete Block Crossover Study of Single Oral Dose GSK835726 (100mg, 50mg, 10mg), Cetirizine (10mg) and Placebo to Evaluate the Efficacy and Safety Using an Environmental Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis

Conditions
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Rhinitis, Allergic, Seasonal

Intervention / Treatment
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* Drug: GSK835726 (10mg)
* Drug: GSK835726 (50mg)
* Drug: GSK835726 (100mg)
* Drug: Cetirizine (10mg)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma. Male Aged 18 - 60 Weight 50kg+, BMI 19-32 kg/m2 Exhibit response to Challenge Chamber and skin prick test. Non-smoker Capable of giving informed consent Exclusion Criteria: No nasal structural abnornmality/polyposis, surgery, infection. any respiratory disease, other than mild asthma or seasonal allergic rhinitis participated in another clinical study within 30 days. Subject has donated a unit of blood within 1 month Use of prescription or non-prescription drugs, including vitamins and st john's wort within 7 days of trial. History of sensitivty to drug History of alcohol/drug abuse within 12 months. Positive Hepatitis B antibody test Positive HIV antibody test Risk of non-compliance with study protocol Perenial allergic rhinitis Administration of oral, injectable or dermal corticosteriods within 8 weeks, intranasal or inhaled within 3 weeks. Past or present disease that may affect outcome, as judge by investigator Specific Immunotherapy within 2 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GSK835726 (10mg)<br>10mg oral dose | Drug: GSK835726 (10mg)<br>* GSK835726 (10mg) tablet<br>|
| Active Comparator: GSK835726 (50mg)<br>50mg oral dose | Drug: GSK835726 (50mg)<br>* GSK835726 (50mg) tablet<br>|
| Active Comparator: GSK835726 (100mg)<br>50mg oral dose | Drug: GSK835726 (100mg)<br>* GSK835726 (100mg) tablet<br>|
| Active Comparator: Cetirizine 10mg<br>10mg cetirizine as active comparator | Drug: Cetirizine (10mg)<br>* Cetirizine (10mg) tablet as positive control<br>|
| Placebo Comparator: placebo<br>placebo tablet | Other: Placebo<br>* Placebo to match active<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in total nasal symptom score 0-4 hours post dose |  | 0-4 hours post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proof-of-Concept, Allergic Rhinitis