Thorough Corrected QT Interval (QTc) Study To Evaluate Possible Effects of Prucalopride on ECG Parameters

Launched by MOVETIS · May 15, 2009

Keywords

ClinConnect Summary

A total number of 120 healthy subjects (with an approximate 1:1 female:male ratio) are planned to be randomised.

Day 1: a baseline ECG profile. Day 1: Group 1 will receive prucalopride, Group 2a will receive moxifloxacin, and Group 2b will receive placebo.

On Day 5 (steady-state level is reached), a full ECG assessment day will be performed, enabling the comparison of prucalopride 2 mg with placebo.

Subsequently, the number of tablets will be escalated in all groups (blinded) with 1 tablet a day up to 5 tablets.

On Day 13 (steady state for the supratherapeutic dose level of 10 mg of pru...

Gender

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Eligibility criteria

• Main Inclusion Criteria:
• • 1. Healthy volunteers aged between 18 to 50 years.
• • 2. Body mass index (BMI) between 18 and 30 kg/m2.
• 3. Female subjects must:
• • be of childbearing potential with a negative serum β-human chorionic gonadotropin (β-HCG) test at screening, and be willing and able to use medically acceptable double barrier methods of birth control, throughout the whole study; or
• • be postmenopausal; or
• • have received surgical sterilisation at least 6 months before screening; AND
• • females must not be receiving hormone replacement therapy (HRT).
• Main exclusion Criteria:
• • 1. Abnormal QTcF and/or heart rate/blood pressure values at baseline.
• • 2. Subjects with ECG abnormalities that may interfere with the accurate assessment of the QT interval.
• • 3. Subjects with known cardiovascular disorders.
• • 4. Subjects with known clinically significant arrhythmias.
• • 5. Subjects with risk factors e.g., Torsades de Pointes.
• • 6. Subjects with clinically relevant, abnormal serum electrolytes or complete blood count (CBC) at screening.
• • 7. Female subjects who are lactating or pregnant.
• • 8. Subjects suffering from other significant medical conditions.
• • 9. Subjects with a known allergy or sensitivity to moxifloxacin, or to prucalopride.
• • 10. Subjects with a positive screening test for hepatitis B, hepatitis C, or HIV at screening.