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

Portola Pharmaceuticals

Status and phase: Terminated; Phase 1

Conditions: Renal Impairment

Treatments: Drug: Elinogrel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00984113

07-115 / CPRT128A2104

Details and patient eligibility

About

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.

Full 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

Enrollment: 44 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

44 participants in 6 patient groups

A-Patients with mild renal impairment

Experimental group

Treatment:

Drug: Elinogrel

B-Healthy subjects matched to Group A

Experimental group

Treatment:

Drug: Elinogrel

C-Patients with moderate renal impairment

Experimental group

Treatment:

Drug: Elinogrel

D-Healthy subjects matched to Group C

Experimental group

Treatment:

Drug: Elinogrel

E-Patients with severe renal impairment

Experimental group

Treatment:

Drug: Elinogrel

F-Healthy subjects matched to Group E

Experimental group

Treatment:

Drug: Elinogrel