NCT00984113

Pharmacokinetics of Elinogrel in Healthy Volunteers and Patients With Mild, Moderate, and Severe Renal Impairment

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Portola Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	Elinogrel	100 mg elinogrel b.i.d. with aspirin q.d. for 7 days and aspirin alone for 4 days (Dose of aspirin is 81 mg in the US and 100 mg in Germany)

Timeline

• Start date: 2009-09-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2009-09-25
• Last updated: 2023-08-04

Locations

2 sites across 1 country: United States