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

This study has been terminated.
(For administrative reasons. Enrollment was sufficient to have statistical power without compromising the integrity of the study data)
Sponsor:
Collaborator:
Novartis
Information provided by:
Portola Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00984113
First received: September 16, 2009
Last updated: November 22, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Renal Impairment
Drug: Elinogrel
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Portola Pharmaceuticals:

Primary Outcome Measures:
  • Pharmacokinetics of elinogrel and its metabolite [ Time Frame: 7 days ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Safety assessments will include vital signs, electrocardiograms and adverse events [ Time Frame: 9 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Platelet aggregation using VerifyNOW P2Y12 assay and thrombi formation using Portola's proprietary PCA (Perfusion Chamber Assay).


Enrollment: 44
Study Start Date: September 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A-Patients with mild renal impairment 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)
Other Name: PRT060128
Experimental: B-Healthy subjects matched to Group A 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)
Other Name: PRT060128
Experimental: C-Patients with moderate renal impairment 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)
Other Name: PRT060128
Experimental: D-Healthy subjects matched to Group C 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)
Other Name: PRT060128
Experimental: E-Patients with severe renal impairment 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)
Other Name: PRT060128
Experimental: F-Healthy subjects matched to Group E 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)
Other Name: PRT060128

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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00984113

Locations
United States, Minnesota
DaVita Clinical Research
Minneapolis, Minnesota, United States, 55404
United States, Tennessee
NOCR-Knoxville
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
Portola Pharmaceuticals
Novartis
Investigators
Study Director: Matthew W McClure, MD Portola Pharmaceuticals Inc.
  More Information

No publications provided

Responsible Party: Matthew W. McClure, MD, Portola Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00984113     History of Changes
Other Study ID Numbers: 07-115 / CPRT128A2104
Study First Received: September 16, 2009
Last Updated: November 22, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Portola Pharmaceuticals:
Elinogrel
Renal impairment
Healthy
Kidney dysfunction

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 28, 2014