Thorough QT Assessment of Cedazuridine in Healthy Subjects

Astex Pharmaceuticals, Inc.36 enrolled

Overview

This study is designed to evaluate the effect of therapeutic and supratherapeutic oral doses of cedazuridine on cardiac repolarization, as detected by QTc in healthy subjects, in accordance with regulatory guidelines. Moxifloxacin will be used to validate the study. Study duration per participant is approximately 20 days.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Volunteers

Interventions

CedazuridineDRUG

Tablet for oral administration

PlaceboDRUG

Capsule for oral administration

MoxifloxacinDRUG

Tablet for oral administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female who is not of childbearing potential * Body mass index of 18.0 to 32.0 kg/m\^2, inclusive Exclusion Criteria: * QTcF \>450 msec at screening * Clinically relevant abnormalities in conduction parameters; or if PR interval \> 200 msec, QRS duration \> 110 msec, or bradycardia or tachycardia (HR \<45 bpm or \>100 bpm) * History or presence of hypokalemia, hypomagnesemia, or hypocalcemia * Risk factors for Torsades de Pointes (TdP) (eg, congenital deafness, heart failure, cardiomyopathy, concomitant medications known to cause QTc prolongation) within a washout of at least 30 days * Family history of Long QT Syndrome or family history of TdP * Sick sinus syndrome, atrioventricular block (any degree) * Myocardial infarction, pulmonary congestion, cardiac arrhythmia, prolonged QT interval, or conduction abnormalities * Repeated or frequent syncope or vasovagal episodes * Resuscitated arrest possibly due to TdP; hypertension, angina, or severe peripheral arterial circulatory disorders * Use of concomitant medications that prolong the QT/QTc interval

Locations (1)

PRA Health Sciences

Groningen, Netherlands

Outcomes

Primary Outcomes

Change from baseline in QTcF

Change from baseline in QTcF following single therapeutic and supratherapeutic doses of cedazuridine