Renal Impairment Study

January 21, 2011 updated by: AstraZeneca

A Phase I, Open Label, Non-randomized, Parallel Group, Pharmacokinetic Study in Subjects With Normal Renal Function, Moderate or Severe Renal Impairment Receiving a Single Dose of Oral 130 mg AZD3355

The purpose of this study is to see how quickly AZD3355 is taken up in to the blood and leaves the blood in people with normal kidney function or with different degrees of reduced kidney function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

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

  • Sweden
      • Linkoping, Sweden
        • Research Site
      • Lulea, Sweden
        • Research Site
      • Uppsala, Sweden
        • Research

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provision of signed informed consent
  • Subjects should have either normal renal function or have a moderate renal impairment or severe renal impairment

Exclusion Criteria:

  • History of heart disease
  • Unstable or clinically significant other disorders such as respiratory, hepatic, metabolic, psychiatric or gastrointestinal disorder

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
AZD3355 65 + 65 mg capsule
Drug: AZD3355
capsule, oral, single dose
Other Names:
  • Lesogaberan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic blood samples
Time Frame: 15 samples during 0-72 hours
15 samples during 0-72 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic urine samples
Time Frame: 8 samples during 72 hours
8 samples during 72 hours

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Wolfgang Kuhn, MD, Quintiles AB, Phase I Services, Strandbodgatan 1, 753 23 Uppsala, Sweden

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

March 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

March 16, 2009

First Submitted That Met QC Criteria

March 16, 2009

First Posted (Estimate)

March 17, 2009

Study Record Updates

Last Update Posted (Estimate)

January 24, 2011

Last Update Submitted That Met QC Criteria

January 21, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9120C00022
  • EudraCTnr 2008-007471-25

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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