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Safety Study of AZD5672 in Renally Impaired Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00715702
First Posted: July 15, 2008
Last Update Posted: April 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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-
First Submitted: July 11, 2008
First Posted: July 15, 2008
Last Update Posted: April 29, 2009
Last Verified: April 2009

Keywords provided by AstraZeneca:
AZD5672

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
N-(1-(3-(3,5-difluorophenyl)-3-(4-methanesulfonylphenyl)propyl)piperidin-4-yl)-N-ethyl-2-(4-methanesulfonylphenyl)acetamide
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents