Back to resultsSafety Study of AZD5672 in Renally Impaired Subjects
Primary Purpose
Renal Impairment
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
AZD5672
Sponsored by
About this trial
This is an interventional basic science trial for Renal Impairment focused on measuring AZD5672
Eligibility 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)
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Patients with Moderate renal impairment and matched volunteers
Patients with Mild or Severe renal impairment and matched volunteers. Type of patient group determined after safety review of 1st group data
Outcomes
Primary Outcome Measures
PK variables
Secondary Outcome Measures
Safety variables (adverse events, blood pressure, pulse, safety lab)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00715702
Brief Title
Safety Study of AZD5672 in Renally Impaired Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Impairment
Keywords
AZD5672
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Patients with Moderate renal impairment and matched volunteers
Arm Title
2
Arm Type
Experimental
Arm Description
Patients with Mild or Severe renal impairment and matched volunteers. Type of patient group determined after safety review of 1st group data
Intervention Type
Drug
Intervention Name(s)
AZD5672
Intervention Description
100 mg oral single dose
Primary Outcome Measure Information:
Title
PK variables
Time Frame
Frequent sampling occasions during study period
Secondary Outcome Measure Information:
Title
Safety variables (adverse events, blood pressure, pulse, safety lab)
Time Frame
During the treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rod Hepburn
Organizational Affiliation
AstraZeneca R&D, Charnwood, UK
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Angelika Weil
Organizational Affiliation
APEX GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
München
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Safety Study of AZD5672 in Renally Impaired Subjects
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