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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.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00836914
First received: February 2, 2009
Last updated: January 4, 2013
Last verified: January 2013
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in total nasal symptom score [ Time Frame: Baseline to Day 35 ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00836914

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

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00836914     History of Changes
Other Study ID Numbers: 101-04
Study First Received: February 2, 2009
Last Updated: January 4, 2013
Health Authority: Austria: Agency for Health and Food Safety

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

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013