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

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ClinicalTrials.gov Identifier: NCT00984113
Recruitment Status : Terminated (For administrative reasons. Enrollment was sufficient to have statistical power without compromising the integrity of the study data)
First Posted : September 25, 2009
Last Update Posted : November 24, 2010
Sponsor:
Collaborator:
Novartis
Information provided by:
Portola Pharmaceuticals

September 16, 2009
September 25, 2009
November 24, 2010
September 2009
December 2009   (Final data collection date for primary outcome measure)
Pharmacokinetics of elinogrel and its metabolite [ Time Frame: 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
Pharmacokinetics of elinogrel and its metabolite [ Time Frame: 7 days ]
Complete list of historical versions of study NCT00984113 on ClinicalTrials.gov Archive Site
  • Safety assessments will include vital signs, electrocardiograms and adverse events [ Time Frame: 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 [ Time Frame: 7 days ]
    Platelet aggregation using VerifyNOW P2Y12 assay and thrombi formation using Portola's proprietary PCA (Perfusion Chamber Assay).
  • Safety assessments will include vital signs, electrocardiograms and adverse events [ Time Frame: 9 days ]
  • Measures of platelet function [ Time Frame: 7 days ]
Not Provided
Not Provided
 
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
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
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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: A-Patients with mild renal impairment
    Intervention: Drug: Elinogrel
  • Experimental: B-Healthy subjects matched to Group A
    Intervention: Drug: Elinogrel
  • Experimental: C-Patients with moderate renal impairment
    Intervention: Drug: Elinogrel
  • Experimental: D-Healthy subjects matched to Group C
    Intervention: Drug: Elinogrel
  • Experimental: E-Patients with severe renal impairment
    Intervention: Drug: Elinogrel
  • Experimental: F-Healthy subjects matched to Group E
    Intervention: Drug: Elinogrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
44
48
December 2009
December 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
Germany
 
NCT00984113
07-115 / CPRT128A2104
No
Not Provided
Not Provided
Matthew W. McClure, MD, Portola Pharmaceuticals, Inc.
Portola Pharmaceuticals
Novartis
Study Director: Matthew W McClure, MD Portola Pharmaceuticals Inc.
Portola Pharmaceuticals
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP