Safety Study of AZD5672 in Renally Impaired Subjects

Renal Impairment Clinical Trial

Official title:

An Open-Label, Single-Centre, Parallel Group, Phase I Study To Compare the Pharmacokinetics of AZD5672 Single Dose in Patients With Renal Impairment and Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00715702
• Other study ID #: D1710C00020
• Secondary ID: EudraCt nr 2007-
• Status: Completed
• Phase: Phase 1
• First received: July 11, 2008
• Last updated: April 28, 2009
• Start date: July 2008
• Est. completion date: February 2009

Study information

• Verified date: April 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• AZD5672
100 mg oral single dose

Locations

Country	Name	City	State
Germany	Research Site	München

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK variables		Frequent sampling occasions during study period	No
Secondary	Safety variables (adverse events, blood pressure, pulse, safety lab)		During the treatment period	Yes