Status:
COMPLETED
A Study To Assess The Effect Of SB-705498 In A Capsaicin Challenge Model
Lead Sponsor:
GlaxoSmithKline
Conditions:
Rhinitis
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This study is designed to look at the affect of SB-705498 on rhinitis symptoms, as induced by capsaicin challenge
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 22 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2009
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00731250
Start Date
July 22 2008
End Date
March 31 2009
Last Update
July 13 2017
Active Locations (1)
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1
GSK Investigational Site
Amsterdam, Netherlands, 1105 AZ