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

Phase 2

Completed

• Conditions: Rhinitis, Allergic, Seasonal
• Interventions: Drug: GSK835726 (50mg); Other: Placebo; Drug: GSK835726 (100mg); Drug: Cetirizine (10mg); Drug: GSK835726 (10mg)

• Registration Number: NCT00851344
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Study First Submitted: 2009-02-24
• Study First Submitted QC: 2009-02-24
• Study First Posted: 2009-02-25
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-04
• Last Update Posted: 2016-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GSK835726 (50mg)	GSK835726 (50mg)	50mg oral dose
placebo	Placebo	placebo tablet
GSK835726 (100mg)	GSK835726 (100mg)	50mg oral dose
Cetirizine 10mg	Cetirizine (10mg)	10mg cetirizine as active comparator
GSK835726 (10mg)	GSK835726 (10mg)	10mg oral dose

Primary Outcome Measures

Name	Time	Method
Change from baseline in total nasal symptom score 0-4 hours post dose	0-4 hours post dose

Trial Locations

Locations (1)

GSK Investigational Site; 🇩🇪 Hannover, Niedersachsen, Germany