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

Renal Impairment Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00984113
• Other study ID #: 07-115 / CPRT128A2104
• Status: Terminated
• Phase: Phase 1
• Start date: September 2009
• Est. completion date: December 2009

Study information

• Verified date: August 2023
• Source: Alexion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

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)

Locations

Country	Name	City	State
United States	NOCR-Knoxville	Knoxville	Tennessee
United States	DaVita Clinical Research	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Portola Pharmaceuticals	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	9 days
Secondary	Measures of platelet function	Platelet aggregation using VerifyNOW P2Y12 assay and thrombi formation using Portola's proprietary PCA (Perfusion Chamber Assay).	7 days