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

Phase 1

Completed

• Conditions: Renal Impairment
• Interventions: Drug: AZD6140

• Registration Number: NCT00733265
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2008-08-12
• Study First Submitted QC: 2008-08-12
• Study First Posted: 2008-08-13
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-02
• Last Update Posted: 2010-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AZD6140	AZD6140	-

Primary Outcome Measures

Name	Time	Method
Blood levels of AZD6140 in patients with severe kidney disease compared to volunteers with normal kidneys	Scheduled times during the 3 days after the study drug is taken

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of AZD6140 in patients with severe kidney disease compared to subjects with normal kidneys	Screening through completion of the study
Measure the effect of AZD6140 on how well blood clots in patients with severe kidney disease compared to subjects with normal kidneys	Scheduled times during the 3 days after the study drug is taken

Trial Locations

Locations (1)

Research Site; 🇺🇸 San Antonio, Texas, United States