Status:
COMPLETED
Intranasal SB-705498 in Allergic Rhinitis (AR) Patients
Lead Sponsor:
GlaxoSmithKline
Conditions:
Rhinitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study is designed to look at the affect of SB-705498 on allergic rhinitis symptoms induced by an allergen chamber challenge.
Eligibility Criteria
Inclusion
- Diagnosis of AR, as determined by the presence of rhinitis symptoms that last for several months per year, for more than 1 year and are not attributed to allergy, infections or nasal abnormalities.
- TNSS score of \>=4 following screening allergen challenge chamber.
- Positive skin prick test for seasonal pollen
- Positive RAST for seasonal pollen
- Healthy as determined by responsible physician with the exception of mild asthma and AR
- Male or female between 18 and 65 years of age inclusive.
- A female subject is eligible to participate if she is of:
- Non-childbearing potential defined as pre-menopausal females with a \\documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) \> 40 MlU/ml and estradiol \< 40 pg/ml (\<147 pmol/L) is confirmatory\].
- Child-bearing potential and agrees to use one of the contraception methods listed as instructed. Female subjects must agree to use contraception until 84 days post-last treatment administration.
- Male subjects with female partners of child-bearing potential must agree to use one contraception as instructed. This must be followed from the time of the first dose of study medication until 84 days post-last treatment administration.
- Body weight ≥ 50 kg (males) and ≥45kg (females) and BMI within the range 19 - 29.9 kg/m2 (inclusive).
- Screening pre-challenge FEV1 greater than or equal to 80% and baselines FEV1/FVC greater than or equal to 70% of predicted value.
- Capable of giving written informed consent.
- Average QTcB, \< 450 msec; or QTc \< 480 msec in subjects with Bundle Branch Block.
- AST and ALT \< 2xULN; alkaline phosphatase and bilirubin less than or equal to 1.5xULN
Exclusion
- Nasal abnormalities likely to affect the outcome of the study,
- History of frequent nosebleeds.
- Respiratory disease other than mild asthma
- A positive pre-study Hepatitis B or Hepatitis C result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
- Positive pre-study drug/alcohol/smoking screen.
- A positive test for HIV antibody.
- History of regular alcohol consumption within 6 months of the study defined as:
- • An average weekly intake of \>14 drinks for males or \>7 drinks for females.
- The subject has participated in a clinical trial and has received an investigational product within 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product prior to D1.
- Exposure to more than four new chemical entities within 12 months prior to D1.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 7 days prior to the first dose of study medication.
- History of sensitivity to any of the study medications, or components
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
- Lactating females.
- Subject is mentally or legally incapacitated.
- Urine cotinine levels indicative of smoking
Key Trial Info
Start Date :
April 14 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2011
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01424397
Start Date
April 14 2011
End Date
July 7 2011
Last Update
September 13 2019
Active Locations (1)
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1
GSK Investigational Site
Vienna, Austria, A-1150