Study Stopped
For administrative reasons. Enrollment was sufficient to have statistical power without compromising the integrity of the study data
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
1 other identifier
interventional
44
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2009
Shorter than P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 16, 2009
CompletedFirst Posted
Study publicly available on registry
September 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedAugust 4, 2023
August 1, 2023
3 months
September 16, 2009
August 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
7 days
Secondary Outcomes (2)
Safety assessments will include vital signs, electrocardiograms and adverse events
9 days
Measures of platelet function
7 days
Study Arms (6)
A-Patients with mild renal impairment
EXPERIMENTALB-Healthy subjects matched to Group A
EXPERIMENTALC-Patients with moderate renal impairment
EXPERIMENTALD-Healthy subjects matched to Group C
EXPERIMENTALE-Patients with severe renal impairment
EXPERIMENTALF-Healthy subjects matched to Group E
EXPERIMENTALInterventions
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 Criteria
You may qualify if:
- Able to understand and sign the written informed consent
- Subjects should have either normal renal function or have stable renal disease
You may not qualify if:
- History of heart disease
- Unstable or clinically significant other disorders such as respiratory, hepatic, metabolic, psychiatric or gastrointestinal disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Portola Pharmaceuticalslead
- Novartiscollaborator
Study Sites (2)
DaVita Clinical Research
Minneapolis, Minnesota, 55404, United States
NOCR-Knoxville
Knoxville, Tennessee, 37920, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Matthew W McClure, MD
Portola Pharmaceuticals Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 16, 2009
First Posted
September 25, 2009
Study Start
September 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
August 4, 2023
Record last verified: 2023-08