Status:
COMPLETED
Safety Study of Prucalopride in Healthy Volunteers
Lead Sponsor:
Movetis
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
In this study healthy volunteers received increasing doses of prucalopride to study the tolerability and cardiac safety of prucalopride. The study hypothesis was that prucalopride at doses up to 10 mg...
Detailed Description
Single-centre, double-blind, placebo-controlled, cross-over study in 33 healthy volunteers with 2 sessions. Each session consisted of a run-in day for baseline assessments, 8 treatment days and 5 addi...
Eligibility Criteria
Inclusion
- Aged between 18 and 45 years.
- Normal weight.
- Healthy on the basis of a pre-study physical examination, medical history, anamnesis,ECG, 24-hour Holter monitoring, echocardiogram and the results of blood biochemistry and haematology tests and a urinalysis carried out in 3 weeks preceding randomisation.
Exclusion
- History or suspicion of alcohol, barbiturate, amphetamine or narcotic abuse.
- Smoking more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 6 months prior to selection.
- History of cardiac arrhythmias, bronchospastic or cardiovascular disease (e.g. ischaemic heart disease or cerebrovascular accident), diabetes mellitus, thyrotoxicosis,Parkinsonism.
- Presence of prolonged QTc (Bazett) on ECG at screening (QTc \>450 ms in male subjects, QTc \>470 ms in female subjects).
- Use of concomitant medication, except for oral contraceptives and paracetamol.
- Participation in an investigational drug study in 30 days prior to the first visit.
- Donation of blood in the 60 days preceding the first visit.
- Pregnancy or breast-feeding female.
- Female subjects of childbearing potential without adequate contraceptive protection during the study.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00793429
Last Update
November 21 2008
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