AZD9164 Single Ascending Dose Study in Healthy Male Subjects | NCT00847249

Studies
AZD9164 Single Ascending Dose Study in Healthy Male Subjects

NCT00847249

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Sep 23, 2009Estimated

Enrollment

65Actual

Phase

Phase 1

Conditions

Healthy

Interventions

AZD9164
Placebo

Countries

Sweden

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

ID	Type	Description	Link
EudraCT No.2008-007188-18

Status Module

Record Verification Date

Sep 2009

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

Feb 2009

Primary Completion Date

Not provided

Completion Date

Apr 2009Actual

First Submitted Date

Feb 12, 2009

First Submission Date that Met QC Criteria

Feb 18, 2009

First Posted Date

Feb 19, 2009Estimated

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 22, 2009

Last Update Posted Date

Sep 23, 2009Estimated

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 aims of the study are to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD9164 following single ascending dose administrations to healthy male subjects.

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

65Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Solution for nebulisation, inhaled	Drug: AZD9164
2	Placebo Comparator	Solution for nebulisation, inhaled	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AZD9164	Drug	Each subject will receive a single-dose starting dose 4µg (lung deposited dose) with up to 8 dose escalations not exceeding AstraZeneca pre-defined exposure limits.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)		up to 48 hours post-dose.

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics		up to 48 hours post-dose.
Local and extrapulmonary effects		up to 48 hours post-dose.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provision of signed, written and dated informed consent prior to any study specific procedures
Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anders Luts	AstraZeneca	Study Director
Ulf Malmqvist	Clinical Trial Unit, Clinical Research and Trial Centre, Lund University Hospital, Lund, Sweden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Lund			Sweden

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
C570585	AZD9164

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided