Safety Study of AZD5672 in Renally Impaired Subjects

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: AZD5672

Study type: Interventional

Funder types: Industry

Identifiers

NCT00715702

EudraCt nr 2007-007541-

D1710C00020

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

1

Experimental group

Description:

Patients with Moderate renal impairment and matched volunteers

Treatment:

Drug: AZD5672

2

Experimental group

Description:

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

Treatment:

Drug: AZD5672