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

Completed · Phase 1

Conditions studied: Kidney Failure, Chronic

In brief

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.

Key facts

Study ID

NCT02022748

Run by

AstraZeneca

People needed

27

Starts

2013-12-29

Expected to finish

2016-05-09

Last updated by the study team

2018-01-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Lakewood, Colorado, United States
• Research Site — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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