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

Phase 1TerminatedNCT00984113

Portola Pharmaceuticals44 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Impairment

Interventions

ElinogrelDRUG

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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

DaVita Clinical Research

Minneapolis, Minnesota, United States

NOCR-Knoxville

Knoxville, Tennessee, United States

Outcomes

Primary Outcomes

Pharmacokinetics of elinogrel and its metabolite

The PK parameters calculated for both elinogrel and PRT060301 were: * AUC0-12h, Cmax, and Tmax on Day 1/Day 7 and T1/2, RACC \& CLR on Day 7 * For elinogrel only, CLss/F and Vss/F were also calculated

Time frame: 7 days

Secondary Outcomes

Safety assessments will include vital signs, electrocardiograms and adverse events

Safety assessments consisted of collecting all adverse events (AEs), serious adverse events (SAEs), with their severity and relationship to study drug, and pregnancies, regular monitoring of hematology, blood chemistry and urinalysis performed at study center. Safety assessments also included periodic ECG evaluations, assessments of vital signs, physical condition, and body weight.

Time frame: 9 days

Measures of platelet function

Platelet aggregation using VerifyNOW P2Y12 assay and thrombi formation using Portola's proprietary PCA (Perfusion Chamber Assay).

Time frame: 7 days

Data from ClinicalTrials.gov

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