Study to Investigate Effects of CAL-101 in Subjects With Allergic Rhinitis Exposed to Allergen in an Environmental Chamber

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.

Inclusion criteria

• 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 criteria

• 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