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NCT00733265 Clinical Trial

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

Renal Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00733265
Other study ID # D5130C00015
Secondary ID AZD6140/Renal St
Status Completed
Phase Phase 1
First received August 12, 2008
Last updated December 2, 2010
Start date February 2007
Est. completion date September 2008

Study information
Verified date December 2010
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date September 2008
Est. primary completion date September 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• AZD6140
single oral dose

Locations
Country Name City State
United States Research Site Anaheim California
United States Research Site Miami Florida
United States Research Site Phoenix Arizona
United States Research Site San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood levels of AZD6140 in patients with severe kidney disease compared to volunteers with normal kidneys Scheduled times during the 3 days after the study drug is taken No
Secondary Safety and tolerability of AZD6140 in patients with severe kidney disease compared to subjects with normal kidneys Screening through completion of the study Yes
Secondary Measure the effect of AZD6140 on how well blood clots in patients with severe kidney disease compared to subjects with normal kidneys Scheduled times during the 3 days after the study drug is taken No
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