Safety Study of AZD5672 in Renally Impaired Subjects

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00715702
First received: July 11, 2008
Last updated: April 28, 2009
Last verified: April 2009
  Purpose

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


Condition Intervention Phase
Renal Impairment
Drug: AZD5672
Phase 1

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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • PK variables [ Time Frame: Frequent sampling occasions during study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety variables (adverse events, blood pressure, pulse, safety lab) [ Time Frame: During the treatment period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: July 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients with Moderate renal impairment and matched volunteers
Drug: AZD5672
100 mg oral single dose
Experimental: 2
Patients with Mild or Severe renal impairment and matched volunteers. Type of patient group determined after safety review of 1st group data
Drug: AZD5672
100 mg oral single dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715702

Locations
Germany
Research Site
München, Germany
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Rod Hepburn AstraZeneca R&D, Charnwood, UK
Principal Investigator: Angelika Weil APEX GmbH
  More Information

No publications provided

Responsible Party: Mark Layton, MD, PhD, Medical Science Director, AstraZeneca R&D Alderely Park
ClinicalTrials.gov Identifier: NCT00715702     History of Changes
Other Study ID Numbers: D1710C00020, EudraCt nr 2007-007541-
Study First Received: July 11, 2008
Last Updated: April 28, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:
AZD5672

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 21, 2014