Status:
COMPLETED
Safety Study of AZD5672 in Renally Impaired Subjects
Lead Sponsor:
AstraZeneca
Conditions:
Renal Impairment
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00715702
Start Date
July 1 2008
End Date
February 1 2009
Last Update
April 29 2009
Active Locations (1)
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1
Research Site
München, Germany