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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00984113

Enrollment

Registered

2009-09-25

Start date

2009-09-30

Completion date

2009-12-31

Last updated

2023-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Impairment

Keywords

Elinogrel, Renal impairment, Healthy, Kidney dysfunction

Brief 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

Interventions

DRUGElinogrel

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)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics of elinogrel and its metabolite	7 days	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

Secondary

Measure	Time frame	Description
Safety assessments will include vital signs, electrocardiograms and adverse events	9 days	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.
Measures of platelet function	7 days	Platelet aggregation using VerifyNOW P2Y12 assay and thrombi formation using Portola's proprietary PCA (Perfusion Chamber Assay).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026