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Completed

NCT Number: NCT04953923

Thorough QT Assessment of Cedazuridine in Healthy Subjects

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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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences

Groningen, 9472NZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cedazuridine

Drug

Tablet for oral administration

Placebo

Drug

Capsule for oral administration

moxifloxacin

Drug

Tablet for oral administration

Primary outcomes

  1. Change from baseline in QTcF

    Time frame: Baseline and Day 20

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

Secondary outcomes

  1. Change from baseline in QTcF

    Time frame: Baseline and Day 20

    Change from baseline in QTcF following cedazuridine-epimer and moxifloxacin administration

  2. Safety: Participants with adverse events

    Time frame: Up to Day 20

    Number of participants with adverse events following single therapeutic and supratherapeutic doses of cedazuridine

  3. Change from baseline in heart rate

    Time frame: Baseline and Day 20

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

  4. Change from baseline in PR interval of the electrocardiogram (ECG)

    Time frame: Baseline and Day 20

    Change from baseline in PR interval of the ECG following single therapeutic and supratherapeutic doses of cedazuridine

  5. Change from baseline in QRS interval of the electrocardiogram (ECG)

    Time frame: Baseline and Day 20

    Change from baseline in QRS interval of the ECG following single therapeutic and supratherapeutic doses of cedazuridine

  6. Change from baseline in T-wave morphology

    Time frame: Baseline to Day 20

    Change from baseline in treatment-emergent T-wave morphology following single therapeutic and supratherapeutic doses of cedazuridine

  7. Pharmacokinetic parameter: Cmax

    Time frame: Up to Day 20

    Cmax is the maximum observed plasma concentration of cedazuridine, cedazuridine-epimer, and moxifloxacin

  8. Pharmacokinetic parameter: Tmax

    Time frame: Up to Day 20

    Tmax is the time to maximum observed plasma concentration of cedazuridine, cedazuridine-epimer, and moxifloxacin

  9. Pharmacokinetic parameter: AUClast

    Time frame: Up to Day 20

    Area under the curve (AUC) from time 0 to time of last measurable concentration of cedazuridine, cedazuridine-epimer, and moxifloxacin

Sponsors and collaborators

Lead sponsor

Astex Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Randomized, Double-blinded, Double-dummy, Placebo-controlled Thorough QTC Study With Single Oral Doses of Cedazuridine in Healthy Subjects

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 8, 2021
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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