NL-OMON50873
Completed
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Leukemia
- Sponsor
- Astex Pharmaceuticals, Inc
- Enrollment
- 36
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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