A RANDOMIZED, DOUBLE-BLINDED, DOUBLE-DUMMY, PLACEBO-CONTROLLED THOROUGH QTC STUDY WITH SINGLE ORAL DOSES OF CEDAZURIDINE IN HEALTHY SUBJECTS
Completed
- Conditions
- Leukemia10024324
- Registration Number
- NL-OMON50873
- Lead Sponsor
- Astex Pharmaceuticals, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
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
syndrome.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the effect of a single therapeutic and supratherapeutic dose of<br /><br>cedazuridine on QTcF in healthy volunteers.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To evaluate the effect of cedazuridine-epimer on QTcF in healthy volunteers<br /><br>To confirm the effect of moxifloxacin on QTcF in healthy subjects for<br /><br>comparison to cedazuridine<br /><br>To evaluate the safety and tolerability of therapeutic and supratherapeutic<br /><br>doses of cedazuridine in healthy subjects<br /><br>To evaluate the effects of a single therapeutic and supratherapeutic dose of<br /><br>cedazuridine on heart rate (HR), PR, QRS intervals, and T-wave morphology.<br /><br>To evaluate the pharmacokinetics (PK) of cedazuridine and the<br /><br>cedazuridine-epimer</p><br>