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

Study Overview
=================
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.

Official Title
-----------------
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Period Crossover Study to Investigate the Safety of CAL-101 in Allergic Rhinitis Subjects and Effects on the Response to Environmental Chamber Allergen Challenge

Conditions
-----------------
Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: CAL-101
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CAL-101<br> | Drug: CAL-101<br>* CAL-101 100mg capsules administered orally twice a day (BID) for 7 days<br>* Other names: GS-1101;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo capsules administered orally BID for 7 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety CAL-101 using adverse events, vital signs, clinical laboratory tests, spirometry and ECG |  | Baseline to Day 35 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in total nasal symptom score |  | Baseline to Day 35 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergic Rhinitis, Allergy, Phosphatidylinositol 3-kinase