Assess the Absorption, Distribution, Metabolism and Excre... | NCT00940641

Studies
Assess the Absorption, Distribution, Metabolism and Excretion of AZD7325 After Intravenous and Oral Administration

NCT00940641

Sponsor

AstraZeneca

Status

Suspended

Last Update Posted

Jan 24, 2011Estimated

Enrollment

8Estimated

Phase

Phase 1

Conditions

Absorption
Distribution
Metabolism
Excretion

Interventions

AZD7325
AZD7325

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

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study withdrawn prior to enrollment due to AZ business decision unrelated to safety.

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Oct 2009Estimated

Completion Date

Oct 2009Estimated

First Submitted Date

Jul 15, 2009

First Submission Date that Met QC Criteria

Jul 15, 2009

First Posted Date

Jul 16, 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

Jan 21, 2011

Last Update Posted Date

Jan 24, 2011Estimated

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 of this study is to evaluate the absorption, distribution, metabolism and excretion of AZD7325 after intravenous and 14C labeled oral 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

8Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	IV dose of AZD7325	Drug: AZD7325
2	Experimental	14C oral dose of AZD7325	Drug: AZD7325

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AZD7325	Drug	IV Dose	1
AZD7325

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess absorption, distribution, metabolism and excretion of AZD7325 after IV dose and 14C oral dose administration		Daily

Secondary Outcomes

Measure	Description	Time Frame
To evaluate safety and tolerability after a single oral administration of [14C] AZD7325 and after a single intravenous administration of non radio-labelled AZD7325		Daily

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy subjects Day 1
Body Mass Index (BMI) > 18 and < 30kg/m2

Exclusion Criteria:

Clinically relevant disease and abnormalities (past or present) which in the opinion of the investigator, may either put the subject at risk to participate in this study or may influence the results of the study or the subject's ability to participate in the study
Use of prescription medication within 14 days of the first dose of the investigational product
Blood loss in excess of 200 mL within 30 days of Day-1 in excess of 500 mL within 90 days of Day-1 or in excess of 1350 mL within 1 year of Day-1 or donation of blood products within 14 days of Day -1

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Raj Chetty, MBBS, MD, FRCPath.	AstraZeneca Alderly Park CPU	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Alderley Park			United Kingdom

Intervention Browse Module

MeSH Terms

ID	Term
C576237	4-amino-8-(2-fluoro-6-methoxy-phenyl)-N-propylcinnoline-3-carboxamide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided