Intranasal SB-705498 in Non-allergic Rhinitis Patients
- Registration Number
- NCT01439308
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This study is designed to look at the affect of SB-705498 on rhinitis symptoms, as induced by capsaicin challenge
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- NAR patients
- 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.
- Subject must demonstrate reactivity to unilateral, intranasal challenge with the selected single dose of capsaicin, defined as development of TSS ≥ 3.
- Normal levels of total plasma IgG and negative allergy skin or Rast test to common aeorallergens.
- Good general health, apart from NAR, as determined by a responsible physician.
Exclusion Criteria
Past medical history of allergic rhinitis or 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Placebo 3 incremental capsaicin doses Arm 2 SB-705498 3 incremental capsaicin doses
- Primary Outcome Measures
Name Time Method Assessment of total symptom score (TSS) after unilateral, incremental dose, intranasal challenge with capsaicin 0-4hours following dosing Assessment of total Ipsilateral secretion's weight after unilateral, incremental dose, intranasal challenge with capsaicin 0-4hours following dosing
- Secondary Outcome Measures
Name Time Method Intranasal, single dose SB-705498 plasma PK parameters- AUC(0-t) 0-4hours post dosing Number of participants with adverse events Day 1 Change from baseline in peak nasal inspiratory flow (PNIF) after unilateral, incremental dose, intranasal challenge with capsaicin 0-4hours following dosing Assessment of Total Contralateral secretion's weight after unilateral, incremental dose, intranasal challenge with capsaicin 0-4hours following dosing Number of participants with Individual Symptoms as assessed by TSS components after unilateral, incremental dose, intranasal challenge with capsaicin 0-4hours Soluble biochemical mediators, including but not limited to neuropeptides, in nasal secretions induced after unilateral, incremental dose, intranasal challenge with capsaicin 0-4hours following dosing Intranasal, single dose SB-705498 plasma PK parameters-Cmax 0-4hours Intranasal, single dose SB-705498 plasma PK parameters- Tmax 0-4hours post dosing Number of participants with vital signs data outside range of potential clinical importance- Systolic blood pressure (SBP) and diastolic blood pressure (DBP) Day 1 Heart rate Day 1 Number of participants with nasal examination data Day 1 Number of participants with abnormal ECG findings Day 1 Body temperature Day 1 Number of participants with abnormal hematology values Day 1 Number of participants with abnormal clinical chemistry values- Carbon dioxide content/Bicarbonate, Cholesterol, Potassium, Triglycerides Day 1 Number of participants with abnormal clinical chemistry values- Creatinine Day 1 Number of participants with abnormal clinical chemistry values- Gamma Glutamyl Transferase, Lactate Dehydrogenase Day 1
Trial Locations
- Locations (1)
GSK Investigational Site
🇳🇱Amsterdam, Netherlands