Trials / Completed
CompletedNCT04953923
Thorough QT Assessment 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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Astex Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cedazuridine | Tablet for oral administration |
| DRUG | Placebo | Capsule for oral administration |
| DRUG | Moxifloxacin | Tablet for oral administration |
Timeline
- Start date
- 2021-07-01
- Primary completion
- 2021-11-15
- Completion
- 2021-11-16
- First posted
- 2021-07-08
- Last updated
- 2024-08-02
Locations
1 site across 1 country: Netherlands
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04953923. Inclusion in this directory is not an endorsement.