Back to resultsRenal Impairment Study
Primary Purpose
Reflux, Renal Excretion
Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
AZD3355
Sponsored by
About this trial
This is an interventional basic science trial for Reflux focused on measuring Safety, tolerability, exposure, healthy, renally impaired subjects
Eligibility Criteria
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
Sites / Locations
- Research Site
- Research Site
- Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
AZD3355 65 + 65 mg capsule
Outcomes
Primary Outcome Measures
Pharmacokinetic blood samples
Secondary Outcome Measures
Pharmacokinetic urine samples
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00863161
Brief Title
Renal Impairment Study
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reflux, Renal Excretion
Keywords
Safety, tolerability, exposure, healthy, renally impaired subjects
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
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
AZD3355 65 + 65 mg capsule
Intervention Type
Drug
Intervention Name(s)
AZD3355
Other Intervention Name(s)
Lesogaberan
Intervention Description
capsule, oral, single dose
Primary Outcome Measure Information:
Title
Pharmacokinetic blood samples
Time Frame
15 samples during 0-72 hours
Secondary Outcome Measure Information:
Title
Pharmacokinetic urine samples
Time Frame
8 samples during 72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Kuhn, MD
Organizational Affiliation
Quintiles AB, Phase I Services, Strandbodgatan 1, 753 23 Uppsala, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Linkoping
Country
Sweden
Facility Name
Research Site
City
Lulea
Country
Sweden
Facility Name
Research
City
Uppsala
Country
Sweden
12. IPD Sharing Statement
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Renal Impairment Study
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