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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: February 4, 2009
Last Update Posted: January 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gilead Sciences
The purpose of this study is to determine the safety and effect of CAL-101 in subjects with allergic rhinitis.

Condition Intervention Phase
Allergic Rhinitis Drug: CAL-101 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Evaluate the safety CAL-101 using adverse events, vital signs, clinical laboratory tests, spirometry and ECG [ Time Frame: Baseline to Day 35 ]

Secondary Outcome Measures:
  • Change from baseline in total nasal symptom score [ Time Frame: Baseline to Day 35 ]

Enrollment: 41
Study Start Date: February 2009
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CAL-101 Drug: CAL-101
CAL-101 100mg capsules administered orally twice a day (BID) for 7 days
Other Names:
  • Idelalisib
  • GS-1101
Placebo Comparator: Placebo Drug: Placebo
Placebo capsules administered orally BID for 7 days

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00836914

Vienna Challenge Chamber
Vienna, Austria
Sponsors and Collaborators
Gilead Sciences
Principal Investigator: Friedrich Horak, MD Vienna Challenge Chamber
  More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00836914     History of Changes
Other Study ID Numbers: 101-04
First Submitted: February 2, 2009
First Posted: February 4, 2009
Last Update Posted: January 8, 2013
Last Verified: January 2013

Keywords provided by Gilead Sciences:
Allergic Rhinitis
Phosphatidylinositol 3-kinase

Additional relevant MeSH terms:
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action