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

Primary Purpose

Renal Impairment

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Elinogrel
Sponsored by
Portola Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Impairment focused on measuring Elinogrel, Renal impairment, Healthy, Kidney dysfunction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • DaVita Clinical Research
  • NOCR-Knoxville

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

A-Patients with mild renal impairment

B-Healthy subjects matched to Group A

C-Patients with moderate renal impairment

D-Healthy subjects matched to Group C

E-Patients with severe renal impairment

F-Healthy subjects matched to Group E

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 16, 2009
Last Updated
August 3, 2023
Sponsor
Portola Pharmaceuticals
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00984113
Brief Title
Pharmacokinetics of Elinogrel in Healthy Volunteers and Patients With Mild, Moderate, and Severe Renal Impairment
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
For administrative reasons. Enrollment was sufficient to have statistical power without compromising the integrity of the study data
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Portola Pharmaceuticals
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Impairment
Keywords
Elinogrel, Renal impairment, Healthy, Kidney dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A-Patients with mild renal impairment
Arm Type
Experimental
Arm Title
B-Healthy subjects matched to Group A
Arm Type
Experimental
Arm Title
C-Patients with moderate renal impairment
Arm Type
Experimental
Arm Title
D-Healthy subjects matched to Group C
Arm Type
Experimental
Arm Title
E-Patients with severe renal impairment
Arm Type
Experimental
Arm Title
F-Healthy subjects matched to Group E
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Elinogrel
Other Intervention Name(s)
PRT060128
Intervention Description
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)
Primary Outcome Measure Information:
Title
Pharmacokinetics of elinogrel and its metabolite
Description
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 Outcome Measure Information:
Title
Safety assessments will include vital signs, electrocardiograms and adverse events
Description
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
Title
Measures of platelet function
Description
Platelet aggregation using VerifyNOW P2Y12 assay and thrombi formation using Portola's proprietary PCA (Perfusion Chamber Assay).
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew W McClure, MD
Organizational Affiliation
Portola Pharmaceuticals Inc.
Official's Role
Study Director
Facility Information:
Facility Name
DaVita Clinical Research
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
NOCR-Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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