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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: AZD6140

Study type: Interventional

Funder types: Industry

Identifiers

NCT00733265

D5130C00015

AZD6140/Renal Study

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 1 patient group

AZD6140

Experimental group

Treatment:

Drug: AZD6140