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Thorough QT Assessment of Cedazuridine in Healthy Subjects

NCT04953923 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-08-02

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Cedazuridine

Tablet for oral administration

DRUG

Placebo

Capsule for oral administration

DRUG

Moxifloxacin

Tablet for oral administration

Sponsors & Collaborators

  • Astex Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2021-11-15
Completion
2021-11-16
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04953923 on ClinicalTrials.gov