Pharmacokinetics, Pharmacodynamics, and Safety Study of Ticagrelor in Hemodialysis Patients and Healthy Subjects

• Status: Completed
• Trial end date: 2016-05-09
• Target enrollment: 0
• Participant gender: All

Summary

A phase I, open-label study comparing the pharmacokinetics, pharmacodynamics, safety and tolerability of ticagrelor in hemodialysis patients to healthy subjects with normal renal function.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Treatments: Polystyrene sulfonic acid; Ticagrelor

Criteria

Inclusion Criteria:

• Male or Female aged 18 to 80 years (inclusive).

• Normal renal function (CrCl of ≥90 mL/min) or End Stage Renal Disease (ESRD) requiring hemodialysis.

Exclusion Criteria:

• Any indication for oral anticoagulant or anti platelet treatment during study period. Must be off treatment for at least 3 weeks (low dose 81mg aspirin is allowed for hemodialysis subjects only).

• Acute Coronary Syndrome (ACS) within past 12 months.

• Contraindications to ticagrelor (ie: active pathological bleeding, severe hepatic impairment, history of hemorrhagic stroke, allergic to ticagrelor).

• Platelet count <100000/μL, hemoglobin <9g/dL

• Blood donation within 90 days of dosing

• Risk for bradycardia

• Investigational drug within 30 days or 6 half-lives, whichever is longer, before dosing

• Concomitant therapy with CYP3A inhibitors/substrates with narrow therapeutic index,or strong CYP3A inducers 14 days before dosing until completion of the follow-up visit.

• History of alcohol, drug, or substance abuse within the past year

• Clinically significant laboratory abnormalities as judged by the investigator.

• Increased bleeding risk including GI bleeding in past 30 days; history of intracranial, retroperitoneal, or spinal bleeding, recent major trauma within 30 days of dosing, Sustained uncontrolled hypertension, history of hemorrhagic disorders.

• Pregnant or lactating females, or females of child-bearing potential (ie, those who are not chemically or surgically sterilised or who are not post-menopause) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator throughout the duration of the study OR females who have a positive pregnancy test at Visit 1.