Study to Assess Safety, Tolerability and Pharmacokinetics... | NCT00754715

Studies
Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD2516 to Healthy Volunteers

NCT00754715

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Dec 15, 2008Estimated

Enrollment

72Estimated

Phase

Phase 1

Conditions

Healthy

Interventions

AZD2516
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
EudractCT: 2008-003598-42

Status Module

Record Verification Date

Dec 2008

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

Sep 2008

Primary Completion Date

Nov 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Sep 16, 2008

First Submission Date that Met QC Criteria

Sep 17, 2008

First Posted Date

Sep 18, 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 12, 2008

Last Update Posted Date

Dec 15, 2008Estimated

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 of this study is to assess the safety and tolerability of AZD2516 following administration of a single dose.

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

72Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AZD2516	Experimental		Drug: AZD2516
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AZD2516	Drug	Solution administered once orally	AZD2516
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability of AZD2516 by assessment of serious adverse events, ECGs, vital signs and laboratory variables		From first to last visit

Secondary Outcomes

Measure	Description	Time Frame
Safety and tolerability of AZD2516 by assessment of non-serious adverse events		Collected from start of residential period until last visit.
Determine the single ascending dose pharmacokinetics of AZD2516		PK sampling taken at defined timepoints during residential period

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy white males or non-fertile females between 20 to 45 years and 65 to 80 years old.
Weight between 50 to 100 kg and a body mass index (BMI) between 19 to 28 kg/m2

Exclusion Criteria:

History of previous or ongoing psychiatric disease.
Abnormalities in ECG that may interfere with interpretation of data.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 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
Bo Fransson, MD	AstraZeneca	Principal Investigator
Lars Ståhle, MD, PhD	AstraZeneca	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Stockholm			Sweden