Study to Evaluate Different Extended Release (ER)-Formula... | NCT00914303

Studies
Study to Evaluate Different Extended Release (ER)-Formulations and Multiple Ascending Dosing of AZD3241

NCT00914303

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Apr 6, 2010Estimated

Enrollment

77Actual

Phase

Phase 1

Conditions

Healthy

Interventions

AZD3241
Placebo Tablet

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 2007-003145-33

Official Title

A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Extended Release Tablets of AZD3241 After Administration of Multiple Ascending Doses in Healthy Male and Female Volunteers Including Food Effect

Status Module

Record Verification Date

Apr 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

Jun 2009

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Jun 1, 2009

First Submission Date that Met QC Criteria

Jun 3, 2009

First Posted Date

Jun 4, 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

Apr 5, 2010

Last Update Posted Date

Apr 6, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 and pharmacokinetics of ER tablets of AZD3241 following multiple ascending doses administered to healthy male and female subjects including the effect of food.

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

77Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AZD3241	Experimental	AZD3241 Tablets	Drug: AZD3241
Placebo	Experimental	Placebo Tablets	Drug: Placebo Tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AZD3241	Drug	Oral Tablet, Repeated Administration	AZD3241
Placebo Tablet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety variables (adverse events, vital signs, ECG, safety lab)		Assessments performed at frequent timepoints during a 4-8 week period

Secondary Outcomes

Measure	Description	Time Frame
To characterize the pharmacokinetics of AZD3241 in plasma		Frequent sampling occasions during some study days for a 4-8 weeks period

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male and female subjects 30-65 years
Body Mass Index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

Exclusion Criteria:

History of any clinically significant disease or disorder
History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
Previous history of frequent pre-syncope or syncope

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rolf Karlsten, MD	Medical Science Director AstraZeneca R&D Södertälje.	Study Director
Wolfgang Kuhn, MD, PhD	Quintiles AB Phase I Unit, Uppsala, Sweden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Uppsala			Sweden

Intervention Browse Module

MeSH Terms

ID	Term
C000602652	AZD3241

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided