Study of an Extended Release (ER) Tablet, Single and Repe... | NCT00689039

Studies
Study of an Extended Release (ER) Tablet, Single and Repeated Dosing

NCT00689039

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Dec 3, 2010Estimated

Enrollment

94Actual

Phase

Phase 1

Conditions

Healthy

Interventions

AZD1305
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
2006-006356-35 (EudraCT No)

Official Title

A Two-part, Single-centre, Open (Part A) Single Blind (Part B), Randomised, Placebo-controlled Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Doses With and Without Food and Multiple Ascending Oral Doses of AZD1305 Extended-release Tablet in Healthy & Elderly Subj

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 2007

Primary Completion Date

Jul 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

May 30, 2008

First Submission Date that Met QC Criteria

Jun 2, 2008

First Posted Date

Jun 3, 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 1, 2010

Last Update Posted Date

Dec 3, 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

The purpose is to study the safety and tolerability of increasing doses of AZD1305 and how the medication is metabolised by the body (how it is taken up, distributed, and how it disappears from the body). The study is performed in healthy volunteers.

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

94Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	AZD1305 ER tablet	Drug: AZD1305
B	Placebo Comparator	Placebo tablet	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AZD1305	Drug	ER tablet, administered as single and repeated doses.	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events, ECG, vital signs, physical examination, laboratory variables, body temperature and weight		During the study

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetic variables		During all dosing visits

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A body mass index (BMI=weight/height2) of 19 to 27 kg/m2
Clinically normal physical findings, laboratory values and resting ECG as judged by the investigator

Exclusion Criteria:

ECG findings outside normal range
Potassium outside normal reference values

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 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
Helen Lunde, MD	AstraZeneca R&D, Mölndal, Sweden	Study Director
Marianne Hartford, MD, PhD	AstraZeneca, Clinical Pharmacology Unit at Sahlgrenska University Hospital, Sweden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Gothenburg			Sweden

Intervention Browse Module

MeSH Terms

ID	Term
C550721	tert-butyl (2-(7-(2-(4-cyano-2-fluorophenoxy)ethyl)-9-oxa-3,7-diazabicyclo(3.3.1)non3-yl)ethyl)carbamate

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided