Study to Investigate Effects of CAL-263 in Subjects With... | NCT01066611

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

NCT01066611

Sponsor

Gilead Sciences

Status

Completed

Last Update Posted

May 5, 2011Estimated

Enrollment

48Estimated

Phase

Phase 1

Conditions

Allergic Rhinitis

Interventions

CAL-263
Placebo

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Jan 27, 2010

First Submission Date that Met QC Criteria

Feb 9, 2010

First Posted Date

Feb 10, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2011

Last Update Posted Date

May 5, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine the safety and effect of CAL-263 in subjects with allergic rhinitis.

Detailed Description

A Phase I, randomized, double-blind crossover study of CAL-263, an oral inhibitor of PI3K delta, in patients with allergic rhinitis.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	CAL-263	Drug: CAL-263
2	Placebo Comparator	Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CAL-263	Drug	CAL-263 10 mg or placebo once daily for 7 days	1
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate the safety of CAL-263 in allergic rhinitis subjects		46 days

Secondary Outcomes

Measure	Description	Time Frame
Determine the efficacy of CAL-263 on total nasal symptom scores following an allergen challenge in allergic rhinitis subjects		7 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >18 and <55 years
Has a history of seasonal allergic rhinitis for at least 2 years
Has sensitivity to grass pollen demonstrated by a positive response to skin prick testing
Has a positive Radio Allergen Sorbent Test (class 2 or greater) for grass pollen during the previous 12 months or at screening
Is otherwise healthy
Is able to provide written informed consent

Exclusion Criteria:

Is a female of childbearing
History of chronic nasal or upper respiratory tract symptoms or disorders other than allergic rhinitis
History of nonallergic rhinitis, chronic sinusitis or severe asthma
Has a nasal condition likely to affect the outcome of the study
Is currently taking regular medication, whether prescribed or not, including corticosteroids, vitamins, macrolides, anti-fungal agents and herbal remedies
Has taken a prohibited medication within the specified interval prior to Visit 1

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Friedrich Horak, MD	Vienna Challenge Chamber	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vienna Challenge Chamber		Vienna			Austria

Condition Browse Module

MeSH Terms

ID	Term
D065631	Rhinitis, Allergic
D006967	Hypersensitivity

Ancestor Terms

ID	Term
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity

Browse Leaves

Not provided

Browse Branches

Not provided