A First Time in Man, Study to Assess the Safety of AZD832... | NCT00935662

Studies
A First Time in Man, Study to Assess the Safety of AZD8329 After Single Ascending Oral Doses

NCT00935662

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Sep 13, 2010Estimated

Enrollment

119Estimated

Phase

Phase 1

Conditions

Healthy Men

Interventions

AZD8329
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. 2009-010702-11

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

Start Date

Jul 2009

Primary Completion Date

Aug 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

Jul 7, 2009

First Submission Date that Met QC Criteria

Jul 8, 2009

First Posted Date

Jul 9, 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 10, 2010

Last Update Posted Date

Sep 13, 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

The primary objective for this study is to assess the safety and tolerability of AZD8329 when given as a single dose in increasing dose strength, and also to identify the highest tolerated dose for future studies.

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

119Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AZD8329	Experimental	AZD8329 oral solution	Drug: AZD8329
Placebo	Placebo Comparator	Placebo for AZD8329 oral solution	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AZD8329	Drug	Oral solution, single ascending doses	AZD8329
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety measurements (ECG's, Pulse, Blood Pressure, Safety Laboratory and Adverse Events)		Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study.

Secondary Outcomes

Measure	Description	Time Frame
PK samples for AZD8329		Intense PK-sampling during the 24 hours following administration of investigational product and additional samples up to 72 hours after dose.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provision of informed consent prior to any study specific procedures
Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg

Exclusion Criteria:

Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject´s ability to participate
Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 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
Wolfgang Kühn	Quintiles AB, Phase I Services, Uppsala, Sweden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Linköping			Sweden
Research Site

Intervention Browse Module

MeSH Terms

ID	Term
C000589241	4-(4-(2-adamantylcarbamoyl)-5-tert-butyl-pyrazol-1-yl)benzoic acid

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided