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Safety Study of AZD5672 in Renally Impaired Subjects

NCT ID: NCT00715702

Last Updated: 2009-04-29

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-02-28

Brief Summary

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The purpose of the study is to investigate the pharmacokinetics of a single dose of AZD5672 in patients with renal impairment by comparing with healthy volunteers

Detailed Description

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Conditions

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Renal Impairment

Keywords

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AZD5672

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

Patients with Moderate renal impairment and matched volunteers

Group Type EXPERIMENTAL

AZD5672

Intervention Type DRUG

100 mg oral single dose

2

Patients with Mild or Severe renal impairment and matched volunteers. Type of patient group determined after safety review of 1st group data

Group Type EXPERIMENTAL

AZD5672

Intervention Type DRUG

100 mg oral single dose

Interventions

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AZD5672

100 mg oral single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of signed written informed consent.
* Females should not be of childbearing potential
* Subjects classified as renally impaired should have been stable (in the Investigator's opinion) for at least 3 months prior to Visit 1.

Exclusion Criteria

* Patients taking prescription of medications: Pgp substrates, inhibitors and /or inducers, medications that affect creatinine clearance(within 7 days of dosing), atorvastatin \>20mg once daily, medications that prolong QT/QTc interval
* Change in dose regimen of prescribed medication and NSAIDs within the 2 weeks before enrolment (renal patients only)
* Participation in another clinical study involving administration of an investigational product in the 3 months prior to treatment (or within 5 half-lives of the last dose of the investigational product, whichever is longer)
Minimum Eligible Age

18 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 R&D Alderely Park

Principal Investigators

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Rod Hepburn

Role: STUDY_DIRECTOR

AstraZeneca R&D, Charnwood, UK

Angelika Weil

Role: PRINCIPAL_INVESTIGATOR

APEX GmbH

Locations

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Research Site

München, , Germany

Site Status

Countries

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Sweden Germany

Other Identifiers

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EudraCt nr 2007-007541-

Identifier Type: -

Identifier Source: secondary_id

D1710C00020

Identifier Type: -

Identifier Source: org_study_id