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Study to Investigate Effects of CAL-263 in Subjects With Allergic Rhinitis Exposed to Allergen in an Environmental Chamber

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01066611
First Posted: February 10, 2010
Last Update Posted: May 5, 2011
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:
Gilead Sciences
January 27, 2010
February 10, 2010
May 5, 2011
January 2010
April 2010   (Final data collection date for primary outcome measure)
Evaluate the safety of CAL-263 in allergic rhinitis subjects [ Time Frame: 46 days ]
Same as current
Complete list of historical versions of study NCT01066611 on ClinicalTrials.gov Archive Site
Determine the efficacy of CAL-263 on total nasal symptom scores following an allergen challenge in allergic rhinitis subjects [ Time Frame: 7 days ]
Same as current
Not Provided
Not Provided
 
Study to Investigate Effects of CAL-263 in Subjects With Allergic Rhinitis Exposed to Allergen in an Environmental Chamber
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Period Crossover Study to Investigate the Safety of CAL-263 in Allergic Rhinitis Subjects and Effects on the Response to Environmental Chamber Allergen Challenge
The purpose of this study is to determine the safety and effect of CAL-263 in subjects with allergic rhinitis.
A Phase I, randomized, double-blind crossover study of CAL-263, an oral inhibitor of PI3K delta, in patients with allergic rhinitis.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Allergic Rhinitis
  • Drug: CAL-263
    CAL-263 10 mg or placebo once daily for 7 days
  • Drug: Placebo
    CAL-263 10 mg or placebo once daily for 7 days
  • Active Comparator: 1
    CAL-263
    Intervention: Drug: CAL-263
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
April 2010
April 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age >18 and <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 (class 2 or greater) for grass pollen during the previous 12 months or at screening
  5. Is otherwise healthy
  6. Is able to provide written informed consent

Exclusion Criteria:

  1. Is a female of childbearing
  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
  5. Is currently taking regular medication, whether prescribed or not, including corticosteroids, vitamins, macrolides, anti-fungal agents and herbal remedies
  6. Has taken a prohibited medication within the specified interval prior to Visit 1
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
 
NCT01066611
263-02
No
Not Provided
Not Provided
Langdon Miller, M.D., VP Clinical Research, Oncology, Gilead Sciences
Gilead Sciences
Not Provided
Principal Investigator: Friedrich Horak, MD Vienna Challenge Chamber
Gilead Sciences
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP