Thorough QT Assessment of Cedazuridine in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2021-11-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment A

Cedazuridine at a therapeutic dose

Group Type EXPERIMENTAL

Cedazuridine

Intervention Type DRUG

Tablet for oral administration

Treatment B

Cedazuridine at a supratherapeutic dose

Group Type EXPERIMENTAL

Cedazuridine

Intervention Type DRUG

Tablet for oral administration

Treatment C

Placebo control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsule for oral administration

Treatment D

Moxifloxacin positive control

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

Tablet for oral administration

Interventions

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Cedazuridine

Tablet for oral administration

Intervention Type DRUG

Placebo

Capsule for oral administration

Intervention Type DRUG

Moxifloxacin

Tablet for oral administration

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes