Renal Impairment Study

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Renal Excretion; Reflux

Treatments: Drug: AZD3355

Study type: Interventional

Funder types: Industry

Identifiers

NCT00863161

EudraCTnr 2008-007471-25

D9120C00022

Details and patient eligibility

About

The purpose of this study is to see how quickly AZD3355 is taken up in to the blood and leaves the blood in people with normal kidney function or with different degrees of reduced kidney function.

Enrollment: 23 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of signed informed consent
• Subjects should have either normal renal function or have a moderate renal impairment or severe renal impairment

Exclusion criteria

• History of heart disease
• Unstable or clinically significant other disorders such as respiratory, hepatic, metabolic, psychiatric or gastrointestinal disorder

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

1

Experimental group

Description:

AZD3355 65 + 65 mg capsule

Treatment:

Drug: AZD3355