A RANDOMIZED, DOUBLE-BLINDED, DOUBLE-DUMMY, PLACEBO-CONTROLLED THOROUGH QTC STUDY WITH SINGLE ORAL DOSES OF CEDAZURIDINE IN HEALTHY SUBJECTS

A RANDOMIZED, DOUBLE-BLINDED, DOUBLE-DUMMY, PLACEBO-CONTROLLED THOROUGH QTC STUDY WITH SINGLE ORAL DOSES OF CEDAZURIDINE IN HEALTHY SUBJECTS - Thorough QT Assessment of Cedazuridine in Healthy Subjects

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50873

Enrollment

Registered

2021-05-17

Start date

2021-06-10

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Interventions

Treatment A: once 100 mg cedazuridine Treatment B: once 400 mg cedazuridine Treatment C: once placebo Treatment D: once 400 mg moxifloxacin

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Sex : male or female; females of nonchildbearing potential, or postmenopausal. 2. Age : 18 to 55 years, inclusive, at screening. 3. Body mass index (BMI) : 18.0 to 32.0 kg/m2, inclusive. 4. Weight : >=50 kg, inclusive. 5. Status : healthy subjects.

Exclusion criteria

Exclusion criteria: 1. Employee of PRA or the Sponsor. 2. History of relevant drug and/or food allergies. 3. History of alcohol abuse or drug addiction (including soft drugs like cannabis products). 4. History or presence of atrioventricular block (any degree) or sick sinus syndrome.

Design outcomes

Primary

Measure	Time frame
To evaluate the effect of a single therapeutic and supratherapeutic dose of cedazuridine on QTcF in healthy volunteers.	—

Secondary

Measure	Time frame
To evaluate the effect of cedazuridine-epimer on QTcF in healthy volunteers To confirm the effect of moxifloxacin on QTcF in healthy subjects for comparison to cedazuridine To evaluate the safety and tolerability of therapeutic and supratherapeutic doses of cedazuridine in healthy subjects To evaluate the effects of a single therapeutic and supratherapeutic dose of cedazuridine on heart rate (HR), PR, QRS intervals, and T-wave morphology. To evaluate the pharmacokinetics (PK) of cedazuridine and the cedazuridine-epimer	—

Measure

Time frame

To evaluate the effect of cedazuridine-epimer on QTcF in healthy volunteers To confirm the effect of moxifloxacin on QTcF in healthy subjects for comparison to cedazuridine To evaluate the safety and tolerability of therapeutic and supratherapeutic doses of cedazuridine in healthy subjects To evaluate the effects of a single therapeutic and supratherapeutic dose of cedazuridine on heart rate (HR), PR, QRS intervals, and T-wave morphology. To evaluate the pharmacokinetics (PK) of cedazuridine and the cedazuridine-epimer

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)