Single Centre, Double-blind, Single and Multiple Ascendin... | NCT01166698

Studies
Single Centre, Double-blind, Single and Multiple Ascending Inhaled Doses of AZD9819 in Healthy Subjects

NCT01166698

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Nov 9, 2011Estimated

Enrollment

100Estimated

Phase

Phase 1

Conditions

Healthy Volunteers
Safety
Tolerability

Interventions

AZD9819
AZD9819
Placebo

Countries

United Kingdom

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

Nov 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

Aug 2010

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

Jul 20, 2010

First Submission Date that Met QC Criteria

Jul 20, 2010

First Posted Date

Jul 21, 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

Nov 8, 2011

Last Update Posted Date

Nov 9, 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 the study is to assess safety and tolerability of AZD9819 following inhaled administration of single and multiple increasing doses, and to estimate the maximum dose that is tolerated in healthy people.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AZD9819	Experimental	Inhaled suspension	Drug: AZD9819
Placebo	Placebo Comparator	Inhaled suspension	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AZD9819	Drug	Inhaled single doses of suspension via SPIRA nebuliser	AZD9819

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety variables (ECG variables, adverse events, blood pressure, pulse, body temp, safety lab)		Frequent safety measurements during the study from screening period to follow-up

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetic variables of AZD9819 by assessment of drug concentrations in plasma		Multiple PK blood samples from pre-dose until 96 hours post last dose

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provision of signed and dated, written informed consent prior to any study specific procedures
Healthy male and female (non-child bearing potential) subjects aged 18 to 50 years with suitable veins for cannulation or repeated venepuncture.
Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

Exclusion Criteria:

Any clinically significant disease or disorder
Any clinically significant abnormalities at screening examination
Use of any prescribed or non-prescribed medication

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		London			United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D053120	Respiratory Aspiration

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000622435	AZD9819

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided