Renal Impairment Study

NCT ID: NCT00863161

Last Updated: 2011-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Reflux Renal Excretion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

AZD3355 65 + 65 mg capsule

Group Type EXPERIMENTAL

AZD3355

Intervention Type DRUG

capsule, oral, single dose

Interventions

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AZD3355

capsule, oral, single dose

Intervention Type DRUG

Other Intervention Names

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Lesogaberan

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Principal Investigators

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Wolfgang Kuhn, MD

Role: PRINCIPAL_INVESTIGATOR

Quintiles AB, Phase I Services, Strandbodgatan 1, 753 23 Uppsala, Sweden

Locations

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Research Site

Linköping, , Sweden

Site Status

Research Site

Luleå, , Sweden

Site Status

Research

Uppsala, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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EudraCTnr 2008-007471-25

Identifier Type: -

Identifier Source: secondary_id

D9120C00022

Identifier Type: -

Identifier Source: org_study_id

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