Status:
COMPLETED
Study to Investigate Effects of CAL-101 in Subjects With Allergic Rhinitis Exposed to Allergen in an Environmental Chamber
Lead Sponsor:
Gilead Sciences
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety and effect of CAL-101 in subjects with allergic rhinitis.
Detailed Description
A Phase I, randomized, double-blind crossover study of CAL-101, an oral inhibitor of phosphatidylinositol 3-kinase (PI3K) delta, in patients with allergic rhinitis.
Eligibility Criteria
Inclusion
- Age \> or = 18 and \< or = 55 years
- Has a history of seasonal allergic rhinitis for at least 2 years
- Has sensitivity to grass pollen demonstrated by a positive response to skin prick testing
- Has a positive Radio Allergen Sorbent Test (\> or = class 2) for grass pollen during the previous 12 months or at screening
- Is otherwise healthy, that is, free from clinically significant illness or disease as determined by medical history, physical examination and laboratory tests, including a normal 12-lead electrocardiogram (ECG)
- Has no conditions which would make the subject unlikely to be able to remain in the allergen challenge chamber for 4 hours
- Is available to complete all study procedures
- Is able to provide written informed consent, including compliance with the requirements and restrictions listed in the consent form
Exclusion
- Is a female of childbearing potential (non-childbearing potential means documented surgery resulting in infertility or postmenopausal with no menses for at least 1 year)
- History of chronic nasal or upper respiratory tract symptoms or disorders other than allergic rhinitis
- History of nonallergic rhinitis, chronic sinusitis or severe asthma
- Has a nasal condition likely to affect the outcome of the study, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases
- Is currently taking regular medication, whether prescribed or not, including corticosteroids, vitamins, macrolides, anti-fungal agents and herbal remedies, e.g. St. John's Wort. Paracetamol (\< or = 2g/day) and as needed use of short-acting B2-agonists are allowed.
- Has taken a prohibited medication within the specified interval prior to Visit 1:
- Corticosteroids (depot, 90 days; systemic, 30 days; dermatologic 14 days)
- Chromones (14 days)
- Antihistamines (nasal and long-acting oral, 10 days; shorting-acting oral, 2 days; ocular, 3 days)
- Decongestants (3 days)
- Leukotriene modifiers (10 days)
- Anticholinergics (7 days)
- Opthalmic nonsteroidal
- anti-inflammatory drugs (3 days)
- Nasal-ophthalmic wash solutions (12 hr)
- Immunotherapy (12 hr)
- Is currently being treated with a medication that induces or inhibits cytochrome P450 (CYP)3A
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00836914
Start Date
February 1 2009
End Date
March 1 2009
Last Update
October 23 2018
Active Locations (1)
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1
Vienna Challenge Chamber
Vienna, Austria