To Study Safety, Tolerability and Pharmacokinetics of AZD... | NCT00738322

Studies
To Study Safety, Tolerability and Pharmacokinetics of AZD1305 in Healthy Male Japanese Subjects

NCT00738322

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jun 30, 2009Estimated

Enrollment

36Estimated

Phase

Phase 1

Conditions

Healthy

Interventions

AZD1305
Placebo

Countries

Japan

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

Jun 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

Jul 2008

Primary Completion Date

Not provided

Completion Date

Oct 2008Actual

First Submitted Date

Jul 11, 2008

First Submission Date that Met QC Criteria

Aug 18, 2008

First Posted Date

Aug 20, 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

Jun 29, 2009

Last Update Posted Date

Jun 30, 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 purpose is to study the safety of AZD1305, how AZD1305 is tolerated and how the medication is metabolised by the body ( how it is taken up into the body, distributed around the body and disappears from the body) in healthy Japanese males.

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

36Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: AZD1305
2	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AZD1305	Drug	Solution for iv infusion, single dose	1
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety by assessment of adverse events, ECG variables, BP, pulse rate, physical examination, laboratory variables, body temperature and body weight		During the study

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetic variables		During the 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
Japanese males

Exclusion Criteria:

ECG findings outside normal reference ranges.
Potassium outside normal reference ranges.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

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
Kyoko Matsuguma, MD	Kyushu Clinical Pharmacology Research Clinic, Fukuoka, Japan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Fukuoka			Japan

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