Status:
COMPLETED
Thorough Corrected QT Interval (QTc) Study To Evaluate Possible Effects of Prucalopride on ECG Parameters
Lead Sponsor:
Movetis
Conditions:
Constipation
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This is a 2-arm, parallel-group active- and placebo-controlled, double-blind randomised study, stratified by gender and with a hybrid crossover group design, to compare treatment with prucalopride 2 m...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Main Inclusion Criteria:
- Healthy volunteers aged between 18 to 50 years.
- Body mass index (BMI) between 18 and 30 kg/m2.
- 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:
- Abnormal QTcF and/or heart rate/blood pressure values at baseline.
- Subjects with ECG abnormalities that may interfere with the accurate assessment of the QT interval.
- Subjects with known cardiovascular disorders.
- Subjects with known clinically significant arrhythmias.
- Subjects with risk factors e.g., Torsades de Pointes.
- Subjects with clinically relevant, abnormal serum electrolytes or complete blood count (CBC) at screening.
- Female subjects who are lactating or pregnant.
- Subjects suffering from other significant medical conditions.
- Subjects with a known allergy or sensitivity to moxifloxacin, or to prucalopride.
- Subjects with a positive screening test for hepatitis B, hepatitis C, or HIV at screening.
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00903747
Start Date
January 1 2009
End Date
May 1 2009
Last Update
May 18 2009
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