AZD 2066 Single Dose Formulation and Food Effect Study in... | NCT00690404

Studies
AZD 2066 Single Dose Formulation and Food Effect Study in Healthy Volunteers

NCT00690404

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Dec 10, 2010Estimated

Enrollment

20Actual

Phase

Phase 1

Conditions

Healthy

Interventions

AZD2066

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

Dec 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

Apr 2008

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Jun 2, 2008

First Submission Date that Met QC Criteria

Jun 3, 2008

First Posted Date

Jun 4, 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

Dec 8, 2010

Last Update Posted Date

Dec 10, 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

A open label two way crossover formulation and food effect study in healthy volunteers to assess the pharmacokinetics of a single dose of AZD2066 new oral solid formulation and an oral solution

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

20Actual

Label	Type	Description	Intervention Names
1	Experimental		Drug: AZD2066

Name	Type	Description	Arm Group Labels	Other Names
AZD2066	Drug	single oral dose	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AZ2066 pharmacokinetics		several samples within 72 hrs

Secondary Outcomes

Measure	Description	Time Frame
Effect of food on AZD2066 pharmacokinetics		several samples over 72 hrs

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical normal physical findings, including BP, pulse rate >45 bpm, ECG and laboratory assessments
Body Mass Index (BMI) of ≥18 to ≤30 kg/m2 and weight of ≥50 to ≤100 kg

Exclusion Criteria:

History of hypersensitivity, allergy or atopic/skin disease as judged by Investigator.
History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the Investigator.

Accepts Healthy Volunteers

Yes

Sex

All

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
Eleanor Lisbon, MD, MPH	Quintiles, Inc. Overland Park, Kansas, USA	Principal Investigator
Heather Wray, MB, ChB, FFPM	AstraZeneca Charnwood England	Study Chair
Ivan Eggens, MD	AstraZeneca , Södertälje, Sweden	Study Chair

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C587779	AZD2066

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided