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

Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00836914
• Other study ID #: 101-04
• Status: Completed
• Phase: Phase 1
• Start date: February 2009
• Est. completion date: March 2009

Study information

• Verified date: January 2013
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and effect of CAL-101 in subjects with allergic rhinitis.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Age > or = 18 and < or = 55 years

2. Has a history of seasonal allergic rhinitis for at least 2 years

3. Has sensitivity to grass pollen demonstrated by a positive response to skin prick testing

4. Has a positive Radio Allergen Sorbent Test (> or = class 2) for grass pollen during the previous 12 months or at screening

5. 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)

6. Has no conditions which would make the subject unlikely to be able to remain in the allergen challenge chamber for 4 hours

7. Is available to complete all study procedures

8. Is able to provide written informed consent, including compliance with the requirements and restrictions listed in the consent form

Exclusion Criteria:

1. 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)

2. History of chronic nasal or upper respiratory tract symptoms or disorders other than allergic rhinitis

3. History of nonallergic rhinitis, chronic sinusitis or severe asthma

4. 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

5. 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.

6. 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)

7. Is currently being treated with a medication that induces or inhibits cytochrome P450 (CYP)3A

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• CAL-101
CAL-101 100mg capsules administered orally twice a day (BID) for 7 days
• Placebo
Placebo capsules administered orally BID for 7 days

Locations

Country	Name	City	State
Austria	Vienna Challenge Chamber	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the safety CAL-101 using adverse events, vital signs, clinical laboratory tests, spirometry and ECG		Baseline to Day 35
Secondary	Change from baseline in total nasal symptom score		Baseline to Day 35