Status:
COMPLETED
Efficacy and Safety Study of BLX-028914 in Subjects With Allergic Rhinitis
Lead Sponsor:
Dart NeuroScience, LLC
Collaborating Sponsors:
Orexo AB
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
This is a phase II study in patients with seasonal allergic rhinitis (SAR) and will compare the effect versus placebo of two different oral doses of BLX-028914 in an allergen challenge model. BLX-0289...
Eligibility Criteria
Inclusion
- 18 to 50 years of age (inclusive), male or female
- Body Mass Index (BMI) between 18 and 28 kg/m2 (inclusive)
- History of pollen-induced seasonal allergic rhinitis but otherwise healthy
- Positive skin prick test for timothy and/or birch allergen
- Sufficient reaction to nasally administered allergen at screening
- Signed informed consent obtained
Exclusion
- Expected symptoms of seasonal allergic rhinitis during the study period
- Asthma
- Nasal anatomical deviations, ongoing nasal symptoms, ongoing upper respiratory tract infection
- Anti-allergy immunotherapy in the previous two years
- Extensive use of nasal sprays
- Any medication except for contraceptives, during their last five half- lives prior to the first treatment period except for occasional OTC analgesics
- Ingestion of grapefruit or grapefruit juice or herbal remedies (e.g. St John's-wort) that may effect the enzyme CYP3A4
- Smoking within 3 months of first treatment period
- Clinically significant laboratory findings
- Pregnant or breast feeding woman or woman of childbearing potential not using adequate birth control
- Known hypersensitivity to any constituent of the study medication or placebo
- Participation in any other investigational study in the last three months
- Subject anticipated not being able to adhere to study plan according to investigator judgement
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00758446
Start Date
September 1 2008
End Date
January 1 2009
Last Update
March 13 2013
Active Locations (1)
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1
Department of otorhinolaryngology
Lund, Sweden, 221 85