Renal Impairment
Conditions
Keywords
Renal Impairment
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.
Interventions
DRUGAZD6140
single oral dose
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of AZD6140 in patients with severe kidney disease compared to subjects with normal kidneys | Screening through completion of the study |
| 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 |
Countries
United States
Outcome results
None listed