Positron Emission Tomography (PET) Study | NCT00886067

Studies
Positron Emission Tomography (PET) Study

NCT00886067

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Sep 10, 2009Estimated

Enrollment

11Actual

Phase

Phase 1

Conditions

Healthy

Interventions

AZD1446
2-[18F]-F-A85380

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. 2008-008390-55

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

Apr 2009

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Apr 21, 2009

First Submission Date that Met QC Criteria

Apr 21, 2009

First Posted Date

Apr 22, 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 9, 2009

Last Update Posted Date

Sep 10, 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 primary purpose is to study the occupancy at the α4β2 neuronal nicotinic receptor's (NNRs) and to determine the relation between plasma concentration of AZD1446 and the occupancy at α4β2 NNRs.

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

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2-[18F]-F-A85380	Experimental	Single microdose	Radiation: 2-[18F]-F-A85380
AZD1446	Experimental	Single oral administration	Drug: AZD1446

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AZD1446	Drug	Solution, oral, single dose	AZD1446
2-[18F]-F-A85380

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determine whether and to what extent AZD1446 can displace radioligand 2-[18F]-F-A85380 from binding to α4β2 neuronal nicotinic receptors (NNRs) and to describe the relationship between plasma concentrations of AZD1446 and its occupancy at α4β2 NNRs.		One PET assessment on baseline day and one PET assessment at the drug treatment day
Plasma concentration (Cmax, tmax, AUC)		During time period of the PET assessment

Secondary Outcomes

Measure	Description	Time Frame
Safety and tolerability (AEs, vital signs, lab)		During the whole study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Physically healthy volunteers
Body weight between 50 to 100 kg and body mass index (BMI) between 19 and 30 kg/m2

Exclusion Criteria:

History of any clinically significant disease or disorder
History of severe allergy/hypersensitivity reactions
Participation in a PET examination as part of a scientific study during the past twelve months

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
Björn Paulsson, MD, PhD	AstraZeneca Södertälje	Study Director
Ingemar, Bylesjö, MD, PhD	AstraZeneca CPU Huddinge	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Stockholm			Sweden

Intervention Browse Module

MeSH Terms

ID	Term
C578484	3-(5-chloro-2-furoyl)-3,7-diazabicyclo(3.3.0)octane
C119803	2-fluoro-3-(2-azetidinylmethoxy)pyridine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided