Overview

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.