Pharmacokinetics of Elinogrel in Healthy Volunteers and Patients With Mild, Moderate, and Severe Renal Impairment
| Status: | Terminated |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 9/27/2018 |
| Start Date: | September 2009 |
| End Date: | December 2009 |
An Open-label, Parallel-group Study to Determine the Single and Multiple Dose Pharmacokinetics of Elinogrel and Its Metabolite in Patients With Mild, Moderate, and Severe Renal Impairment Compared to Healthy Subjects
The purpose of the study is to determine the pharmacokinetics and safety of elinogrel and its
metabolite in patients with mild, moderate, and severe renal impairment compared to healthy
volunteers.
metabolite in patients with mild, moderate, and severe renal impairment compared to healthy
volunteers.
Multiple-dose, open-label parallel-group design in patients with mild, moderate or severe
renal impairment and age (±7 years), sex and weight (±15% BMI) matched healthy subjects.
- mild renal impairment: CrCl from 50 to ≤80 ml/min
- moderate renal impairment: CrCl from 30 to <50 ml/min
- severe renal impairment: CrCl of <30 ml/min
renal impairment and age (±7 years), sex and weight (±15% BMI) matched healthy subjects.
- mild renal impairment: CrCl from 50 to ≤80 ml/min
- moderate renal impairment: CrCl from 30 to <50 ml/min
- severe renal impairment: CrCl of <30 ml/min
Inclusion Criteria:
- Able to understand and sign the written informed consent
- Subjects should have either normal renal function or have stable renal disease
Exclusion Criteria:
- History of heart disease
- Unstable or clinically significant other disorders such as respiratory, hepatic,
metabolic, psychiatric or gastrointestinal disorder
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