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Study to Investigate the Effects of AZD6140 in Patients With Renal Impairment and in Healthy Volunteers

Primary Purpose

Renal Impairment

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AZD6140
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Renal Impairment focused on measuring Renal Impairment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients must have severe kidney disease
  • Subjects who are matched to the kidney disease patients in terms of weight, age, and sex must have normal kidneys
  • All women must be post-menopausal (no longer menstruating) or surgically sterile

Exclusion Criteria:

  • Patients requiring dialysis
  • History of allergy to aspirin or clopidogrel
  • Have increased bleeding risk (for instance uncontrolled high blood pressure or a recent major injury)
  • Recent history of fainting or light-headedness

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AZD6140

Arm Description

Outcomes

Primary Outcome Measures

Blood levels of AZD6140 in patients with severe kidney disease compared to volunteers with normal kidneys

Secondary Outcome Measures

Safety and tolerability of AZD6140 in patients with severe kidney disease compared to subjects with normal kidneys
Measure the effect of AZD6140 on how well blood clots in patients with severe kidney disease compared to subjects with normal kidneys

Full Information

First Posted
August 12, 2008
Last Updated
December 2, 2010
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00733265
Brief Title
Study to Investigate the Effects of AZD6140 in Patients With Renal Impairment and in Healthy Volunteers
Official Title
Study to Investigate the Effects of AZD6140 in Patients With Renal Impairment and in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The main purpose of this study is to examine how AZD6140 affects patients with severe kidney disease compared to volunteers with normal kidneys. Subjects in the study will receive one dose of AZD6140.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Impairment
Keywords
Renal Impairment

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AZD6140
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
AZD6140
Intervention Description
single oral dose
Primary Outcome Measure Information:
Title
Blood levels of AZD6140 in patients with severe kidney disease compared to volunteers with normal kidneys
Time Frame
Scheduled times during the 3 days after the study drug is taken
Secondary Outcome Measure Information:
Title
Safety and tolerability of AZD6140 in patients with severe kidney disease compared to subjects with normal kidneys
Time Frame
Screening through completion of the study
Title
Measure the effect of AZD6140 on how well blood clots in patients with severe kidney disease compared to subjects with normal kidneys
Time Frame
Scheduled times during the 3 days after the study drug is taken

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients must have severe kidney disease Subjects who are matched to the kidney disease patients in terms of weight, age, and sex must have normal kidneys All women must be post-menopausal (no longer menstruating) or surgically sterile Exclusion Criteria: Patients requiring dialysis History of allergy to aspirin or clopidogrel Have increased bleeding risk (for instance uncontrolled high blood pressure or a recent major injury) Recent history of fainting or light-headedness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Butler, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Anaheim
State/Province
California
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21960668
Citation
Butler K, Teng R. Pharmacokinetics, pharmacodynamics, and safety of ticagrelor in volunteers with severe renal impairment. J Clin Pharmacol. 2012 Sep;52(9):1388-98. doi: 10.1177/0091270011415526. Epub 2011 Sep 29.
Results Reference
derived

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Study to Investigate the Effects of AZD6140 in Patients With Renal Impairment and in Healthy Volunteers

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