Allergen Challenge Chamber Study With Single Dose Intranasal GSK1004723 Compared With Placebo

Study Overview
=================
Brief Summary
-----------------
This is a placebo-controlled, 3-period crossover study to assess the efficacy and safety of two single doses of an intranasal anti-histamine GSK1004723 compared with placebo in an allergen challenge chamber in male subjects with seasonal allergic

Official Title
-----------------
A Randomised, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Assess the Efficacy and Safety of Single Dose Intranasal GSK1004723 Compared With Placebo in an Allergen Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis

Conditions
-----------------
Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: GSK1004723 (200mg)
* Other: Placebo
* Drug: GSK1004723 (1000mg)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma. Male Aged 18 - 65 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
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GSK1004726 (1000mg)<br>1000mg aqueous suspension | Drug: GSK1004723 (1000mg)<br>* Intranasal antihistamine.<br>|
| Placebo Comparator: Placebo<br>Intranasal spray | Other: Placebo<br>* Equivalent to GSK1004723 in presentation etc.<br>Drug: GSK1004723 (1000mg)<br>* Intranasal antihistamine.<br>|
| Active Comparator: GSK1004723 (200mg)<br>200 mg aqueous suspension | Drug: GSK1004723 (200mg)<br>* Intranasal antihistamine.<br>|

What is the study measuring?
-----------------
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
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergic Rhinitis, Proof-of-Concept