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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Cedazuridine at a therapeutic dose |
|
| Treatment B | Experimental | Cedazuridine at a supratherapeutic dose |
|
| Treatment C | Placebo Comparator | Placebo control |
|
| Treatment D | Active Comparator | Moxifloxacin positive control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cedazuridine | Drug | Tablet for oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in QTcF | Change from baseline in QTcF following single therapeutic and supratherapeutic doses of cedazuridine | Baseline and Day 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in QTcF | Change from baseline in QTcF following cedazuridine-epimer and moxifloxacin administration | Baseline and Day 20 |
| Safety: Participants with adverse events | Number of participants with adverse events following single therapeutic and supratherapeutic doses of cedazuridine |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences | Groningen | 9472NZ | Netherlands |
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| ID | Term |
|---|---|
| C000633944 | cedazuridine |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Placebo |
| Drug |
Capsule for oral administration |
|
| Moxifloxacin | Drug | Tablet for oral administration |
|
| Up to Day 20 |
| Change from baseline in heart rate | Change from baseline in heart rate following single therapeutic and supratherapeutic doses of cedazuridine | Baseline and Day 20 |
| Change from baseline in PR interval of the electrocardiogram (ECG) | Change from baseline in PR interval of the ECG following single therapeutic and supratherapeutic doses of cedazuridine | Baseline and Day 20 |
| Change from baseline in QRS interval of the electrocardiogram (ECG) | Change from baseline in QRS interval of the ECG following single therapeutic and supratherapeutic doses of cedazuridine | Baseline and Day 20 |
| Change from baseline in T-wave morphology | Change from baseline in treatment-emergent T-wave morphology following single therapeutic and supratherapeutic doses of cedazuridine | Baseline to Day 20 |
| Pharmacokinetic parameter: Cmax | Cmax is the maximum observed plasma concentration of cedazuridine, cedazuridine-epimer, and moxifloxacin | Up to Day 20 |
| Pharmacokinetic parameter: Tmax | Tmax is the time to maximum observed plasma concentration of cedazuridine, cedazuridine-epimer, and moxifloxacin | Up to Day 20 |
| Pharmacokinetic parameter: AUClast | Area under the curve (AUC) from time 0 to time of last measurable concentration of cedazuridine, cedazuridine-epimer, and moxifloxacin | Up to Day 20 |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |