Safety and Tolerability of Single and Multiple Doses of V... | NCT00620230

Studies
Safety and Tolerability of Single and Multiple Doses of VAK694 in Healthy and Atopic Subjects

NCT00620230

Sponsor

Novartis

Status

Completed

Last Update Posted

Sep 27, 2010Estimated

Enrollment

46Actual

Phase

Phase 1

Conditions

Allergic Rhinitis

Interventions

NVP-VAK694
NVP-VAK694

Countries

United States

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

Sep 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Oct 2007

Primary Completion Date

Apr 2008Actual

Completion Date

Apr 2008Actual

First Submitted Date

Feb 7, 2008

First Submission Date that Met QC Criteria

Feb 7, 2008

First Posted Date

Feb 21, 2008Estimated

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

Sep 24, 2010

Last Update Posted Date

Sep 27, 2010Estimated

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

This study will evaluate the safety and tolerability of single and multiple doses of VAK694 in healthy volunteers and otherwise healthy volunteers with a history of allergies.

Detailed Description

Not provided

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

46Actual

Label	Type	Description	Intervention Names
1	Experimental		Drug: NVP-VAK694
2	Placebo Comparator		Drug: NVP-VAK694

Name	Type	Description	Arm Group Labels	Other Names
NVP-VAK694	Drug		1
NVP-VAK694

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Routine safety observations and pharmacokinetic measurements		throughout the study

Secondary Outcomes

Measure	Description	Time Frame
Routine safety observations and pharmacokinetic measurements		throughout the study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

History of allergic rhinitis (Part 2 only)

Exclusion Criteria:

Very low or high body weight
Heavy or recent smoker
Exposure to human monoclonal antibodies

Other protocol-defined inclusion/exclusion criteria may apply.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis	Novartis investigator site	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigator Site		North Miami Beach	Florida	33169	United States

Condition Browse Module

MeSH Terms

ID	Term
D065631	Rhinitis, Allergic

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided