Safety Study of AZD5672 in Renally Impaired Subjects

Phase 1

Completed

Brief Summary: 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

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
1	AZD5672	Patients with Moderate renal impairment and matched volunteers
2	AZD5672	Patients with Mild or Severe renal impairment and matched volunteers. Type of patient group determined after safety review of 1st group data

Primary Outcome Measures

Name	Time	Method
PK variables	Frequent sampling occasions during study period

Secondary Outcome Measures

Name	Time	Method
Safety variables (adverse events, blood pressure, pulse, safety lab)	During the treatment period

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