Study to Investigate the Effects of AZD6140 in Patients With Renal Impairment and in Healthy Volunteers

This study has been completed.

First Received: August 12, 2008 Last Updated: April 14, 2009 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00733265

Purpose

The main purpose of this study is to examine how AZD6140 affects patients with severe kidney disease compared to volunteers with normal kidneys. Subjects in the study will receive one dose of AZD6140.

Condition	Intervention	Phase
Renal Impairment	Drug: AZD6140	Phase I

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study
Official Title:	Study to Investigate the Effects of AZD6140 in Patients With Renal Impairment and in Healthy Volunteers

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Blood levels of AZD6140 in patients with severe kidney disease compared to volunteers with normal kidneys [ Time Frame: Scheduled times during the 3 days after the study drug is taken ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability of AZD6140 in patients with severe kidney disease compared to subjects with normal kidneys [ Time Frame: Screening through completion of the study ] [ Designated as safety issue: Yes ]
Measure the effect of AZD6140 on how well blood clots in patients with severe kidney disease compared to subjects with normal kidneys [ Time Frame: Scheduled times during the 3 days after the study drug is taken ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	February 2007
Study Completion Date:	November 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
AZD6140: Experimental	Drug: AZD6140 single oral dose

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patients must have severe kidney disease
Subjects who are matched to the kidney disease patients in terms of weight, age, and sex must have normal kidneys
All women must be post-menopausal (no longer menstruating) or surgically sterile

Exclusion Criteria:

Patients requiring dialysis
History of allergy to aspirin or clopidogrel
Have increased bleeding risk (for instance uncontrolled high blood pressure or a recent major injury)
Recent history of fainting or light-headedness

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733265

Locations

United States, Arizona
Research Site
Phoenix, Arizona, United States
United States, California
Research Site
Anaheim, California, United States
United States, Florida
Research Site
Miami, Florida, United States
United States, Texas
Research Site
San Antonio, Texas, United States

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Kathleen Butler, MD

AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( Jay Horrow, MD, Medical Science Director, AZD6140 )
Study ID Numbers:	D5130C00015, AZD6140/Renal Study
Study First Received:	August 12, 2008
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00733265 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Renal Impairment

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on August 25, 2009