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

NCT ID: NCT00836914

Last Updated: 2018-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2009-03-31

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.

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CAL-101

Group Type: ACTIVE_COMPARATOR

CAL-101

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo capsules administered orally BID for 7 days

Interventions

CAL-101

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

Intervention Type: DRUG

Placebo

Placebo capsules administered orally BID for 7 days

Intervention Type: DRUG

Other Intervention Names

Idelalisib; GS-1101

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Friedrich Horak, MD

Role: PRINCIPAL_INVESTIGATOR

Vienna Challenge Chamber

Locations

Vienna Challenge Chamber

Vienna, , Austria

Countries

Austria

References

Horak F, Puri KD, Steiner BH, Holes L, Xing G, Zieglmayer P, Zieglmayer R, Lemell P, Yu A. Randomized phase 1 study of the phosphatidylinositol 3-kinase delta inhibitor idelalisib in patients with allergic rhinitis. J Allergy Clin Immunol. 2016 Jun;137(6):1733-1741. doi: 10.1016/j.jaci.2015.12.1313. Epub 2016 Feb 23.

Reference Type: DERIVED

PMID: 26915677 (View on PubMed)

Other Identifiers

101-04

Identifier Type: -

Identifier Source: org_study_id