Pharmacokinetics of Elinogrel in Healthy Volunteers and Patients With Mild, Moderate, and Severe Renal Impairment
- Registration Number
- NCT00984113
- Lead Sponsor
- Portola Pharmaceuticals
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 44
- Able to understand and sign the written informed consent
- Subjects should have either normal renal function or have stable renal disease
- History of heart disease
- Unstable or clinically significant other disorders such as respiratory, hepatic, metabolic, psychiatric or gastrointestinal disorder
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A-Patients with mild renal impairment Elinogrel - D-Healthy subjects matched to Group C Elinogrel - F-Healthy subjects matched to Group E Elinogrel - C-Patients with moderate renal impairment Elinogrel - B-Healthy subjects matched to Group A Elinogrel - E-Patients with severe renal impairment Elinogrel -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Measures of platelet function 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 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.
Trial Locations
- Locations (2)
DaVita Clinical Research
🇺🇸Minneapolis, Minnesota, United States
NOCR-Knoxville
🇺🇸Knoxville, Tennessee, United States
DaVita Clinical Research🇺🇸Minneapolis, Minnesota, United States