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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00851344

Enrollment

Registered

2009-02-25

Start date

2008-09-30

Completion date

2008-11-30

Last updated

2016-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinitis, Allergic, Seasonal

Keywords

Proof-of-Concept, Allergic Rhinitis

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

Interventions

DRUGGSK835726 (10mg)

GSK835726 (10mg) tablet

DRUGGSK835726 (50mg)

GSK835726 (50mg) tablet

DRUGGSK835726 (100mg)

GSK835726 (100mg) tablet

DRUGCetirizine (10mg)

Cetirizine (10mg) tablet as positive control

OTHERPlacebo

Placebo to match active

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in total nasal symptom score 0-4 hours post dose	0-4 hours post dose

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026