a study to assess the effect of sb-705498 in a capsaicin challenge model

Conditions: Rhinitis

Summary: this study is designed to look at the affect of sb-705498 on rhinitis symptoms, as induced by capsaicin challenge


Eligibility criteria:
inclusion criteria: * healthy. * male or female between 18 and 60 years of age inclusive. * non-child bearing women or women of child bearing potential if they agree to use contraception as indicated by the protocol * non-smoker for at least 6 months with a pack history \<5 pack years (pack years = (no. of cigarettes smoked/day/20) x no. of years smoked). * body weight \> 50 kg and body mass index (bmi) within the range 19 - 29.9 kg/m2 (inclusive). * capable of giving written informed consent. * available to complete all the required study measurements. * normal 12-lead ecg at screening. * for part 2 only: the subject must demonstrate reactivity to unilateral, intranasal challenge with the selected single dose of capsaicin, defined as development of tss ≥ 3. exclusion criteria: * past medical history of rhinitis, including allergic, non-allergic rhinitis and rhinosinusitis. * nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforation, nasal polyps, other nasal malformations. * a history of gastrointestinal, hepatic, renal or multiple cardiovascular risk factors. * positive pre-study drug/alcohol screen. * positive pre-study hepatitis b surface antigen or positive hepatitis c antibody result within 3 months of screening. * a positive test for human immunodeficiency virus (hiv) antibody (if determined by the local standard operating procedures (sops)). * history of regular alcohol consumption within 6 months of the study. * exposure to more than four new chemical entities within 12 months prior to the start of the study. * participation in a clinical trial with a new molecule entity or any other clinical trial within 4 months of the start of the study. * use of prescription or non-prescription drugs, as well as of vitamins, herbal and dietary supplements (including st john's wort) within 2 days prior to each study visit in part 1 of the study or 14 days prior to the first treatment administration in part 2 of the study. * inability to abstain from all intranasal or oral medication to treat nasal symptoms from the first capsaicin challenge to the completion of the study including: sodium cromoglycate, antihistamines, anticholinergics, alpha-adrenergic agonists and corticosteroids * history of drug or other allergy that, in the opinion of the investigator or gsk medical monitor, contraindicates their participation. * subjects demonstrating hypersensitivity to the placebo capsaicin challenge at baseline screening. * donation of blood or blood products in excess of 500ml within a 56 day period prior the start of part 2 of this study. * pregnant females as determined by positive serum or urine human chorionic gonadotropin (hcg) test at screening or prior to dosing. * lactating females. * unwillingness or inability to follow the procedures outlined in the protocol. * history of sensitivity to heparin or heparin-induced thrombocytopenia. * nicotine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening. * for part 2 only: subjects with known lactose intolerance.

Keywords: capsaicin challenge