AZD6088 Single Ascending Dose Study | NCT00931541

Studies
AZD6088 Single Ascending Dose Study

NCT00931541

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Sep 10, 2009Estimated

Enrollment

35Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

AZD6088
Placebo

Countries

United Kingdom

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 N0. 2008-007936-17

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

Jun 2009

Primary Completion Date

Not provided

Completion Date

Aug 2009Actual

First Submitted Date

Jun 30, 2009

First Submission Date that Met QC Criteria

Jun 30, 2009

First Posted Date

Jul 2, 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 aims of the study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD6088 following single ascending dose administration in healthy male and non-fertile females.

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

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	AZD6088 oral solution	Drug: AZD6088
B	Experimental	Placebo oral solution	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AZD6088	Drug	Oral solution. Each subject will receive a single-dose of AZD6088.	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety variables (vital signs, ECG, EEG, safety laboratory values, body temp)		Sampling occasions during all visits.

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics		Intense PK-sampling during 3 pre-defined study days for PK profiling.
Pharmacodynamics		Sampling occasions during 3 pre-defined study days.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Caucasian male and non-fertile female healthy volunteers aged ≥18 to ≤55 years with suitable veins for cannulation or repeated venipuncture.
Clinically normal physical findings including supine BP, pulse rate, ECG and laboratory assessments in relation to age, as judged by the investigator.
Normal and suitable EEG, as judged by a neurologist

Exclusion Criteria:

History of any clinically significant disease or disorder which for instance includes CNS disorder or CV disorder.
Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator.
Any clinically important abnormalities in the ECG.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Biljana Lilja	AstraZeneca R&D, Södertälje, Sweden	Study Director
Marianne Kasti	Quintiles GDRU, London, UK	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		London Bridge	Greater London		United Kingdom

Intervention Browse Module

MeSH Terms

ID	Term
C579428	AZD6088

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided