Clinical trial NCT00731250: A Study To Assess The Effect Of SB-705498 In A Capsaicin Challenge Model
Official title: A Randomised, Double-blind, Placebo-controlled Study to Assess the Effect of Oral, Single Dose SB-705498 in a Validated Intranasal Capsaicin Challenge Model in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rhinitis
Keywords: Capsaicin challenge
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-08-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Symptom scores and secretion weights
timeFrame: up to 83 days
Secondary outcomes:
measure: Peak nasal inspiratory flow changes after challenge
timeFrame: up to 83 days
measure: Biomarkers levels in the nasal samples
timeFrame: up to 83 days
measure: Blood levels of drug
timeFrame: up to 83 days
measure: Pharmacodynamic response
timeFrame: up to 83 days
measure: Safety parameters
timeFrame: up to 83 days
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: