A Study To Assess The Effect Of SB-705498 In A Capsaicin Challenge Model

• Status: Completed
• Trial end date: 2009-03-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to look at the affect of SB-705498 on rhinitis symptoms, as induced by capsaicin challenge

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Capsaicin

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.