This study is designed to look at the affect of SB-705498 on rhinitis symptoms, as induced by capsaicin challenge
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
GSK Investigational Site
Amsterdam, Netherlands
Assessment of total symptom score (TSS) after unilateral, incremental dose, intranasal challenge with capsaicin
Time frame: 0-4hours following dosing
Assessment of total Ipsilateral secretion's weight after unilateral, incremental dose, intranasal challenge with capsaicin
Time frame: 0-4hours following dosing
Change from baseline in peak nasal inspiratory flow (PNIF) after unilateral, incremental dose, intranasal challenge with capsaicin
Time frame: 0-4hours following dosing
Assessment of Total Contralateral secretion's weight after unilateral, incremental dose, intranasal challenge with capsaicin
Time frame: 0-4hours following dosing
Number of participants with Individual Symptoms as assessed by TSS components after unilateral, incremental dose, intranasal challenge with capsaicin
Time frame: 0-4hours
Soluble biochemical mediators, including but not limited to neuropeptides, in nasal secretions induced after unilateral, incremental dose, intranasal challenge with capsaicin
Time frame: 0-4hours following dosing
Intranasal, single dose SB-705498 plasma PK parameters-Cmax
Time frame: 0-4hours
Intranasal, single dose SB-705498 plasma PK parameters- Tmax
Time frame: 0-4hours post dosing
Intranasal, single dose SB-705498 plasma PK parameters- AUC(0-t)
Time frame: 0-4hours post dosing
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Number of participants with adverse events
Time frame: Day 1
Number of participants with vital signs data outside range of potential clinical importance- Systolic blood pressure (SBP) and diastolic blood pressure (DBP)
Time frame: Day 1
Heart rate
Time frame: Day 1
Number of participants with nasal examination data
Time frame: Day 1
Number of participants with abnormal ECG findings
Time frame: Day 1
Body temperature
Time frame: Day 1
Number of participants with abnormal hematology values
Time frame: Day 1
Number of participants with abnormal clinical chemistry values- Carbon dioxide content/Bicarbonate, Cholesterol, Potassium, Triglycerides
Time frame: Day 1
Number of participants with abnormal clinical chemistry values- Creatinine
Time frame: Day 1
Number of participants with abnormal clinical chemistry values- Gamma Glutamyl Transferase, Lactate Dehydrogenase
Time frame: Day 1