Safety Study of AZD5672 in Renally Impaired Subjects

April 28, 2009 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • München, Germany
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PK variables
Time Frame: Frequent sampling occasions during study period
Frequent sampling occasions during study period

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety variables (adverse events, blood pressure, pulse, safety lab)
Time Frame: During the treatment period
During the treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Angelika Weil, Apex Gmbh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ACTUAL)

February 1, 2009

Study Completion (ACTUAL)

February 1, 2009

Study Registration Dates

First Submitted

July 11, 2008

First Submitted That Met QC Criteria

July 11, 2008

First Posted (ESTIMATE)

July 15, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 29, 2009

Last Update Submitted That Met QC Criteria

April 28, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1710C00020
  • EudraCt nr 2007-007541-

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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