AZD8529 Multiple Ascending Dose Study in Healthy Subjects | NCT00765492

Studies
AZD8529 Multiple Ascending Dose Study in Healthy Subjects

NCT00765492

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jun 26, 2009Estimated

Enrollment

47Estimated

Phase

Phase 1

Conditions

Healthy Volunteer

Interventions

AZD8529
Placebo

Countries

Not provided

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

Jun 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

Oct 2008

Primary Completion Date

Not provided

Completion Date

Mar 2009Actual

First Submitted Date

Oct 2, 2008

First Submission Date that Met QC Criteria

Oct 2, 2008

First Posted Date

Oct 3, 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

Jun 25, 2009

Last Update Posted Date

Jun 26, 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

This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD8529 after multiple ascending doses

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

47Estimated

Label	Type	Description	Intervention Names
1	Experimental		Drug: AZD8529
2	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
AZD8529	Drug	oral	1
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the safety and tolerability of multiple dose administration of AZD8529 when given orally to healthy male subjects and female subjects of non-childbearing potential.		each visit, at least daily, during the study.

Secondary Outcomes

Measure	Description	Time Frame
To characterize the pharmacokinetics of AZD8529 in plasma		Blood samples will be taken during the study.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female subjects must be of non-child bearing potential.

Exclusion Criteria:

Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 30months of the first administration of investigational prod
Plasma donation within one month of screening or any blood donation/blood loss > 500mL during the 3 months prior to screening
Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis

Accepts Healthy Volunteers

Yes

Sex

All

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

Name	Affiliation	Role
Mark Smith, MD, PhD	AstraZeneca	Study Director

Intervention Browse Module

MeSH Terms

ID	Term
C000608263	AZD8529

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided