Safety Study of Prucalopride in Healthy Volunteers

NCT00793429 | Completed Phase 1

• 1 other identifier: GBR-9
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 has no clinically relevant effect on the cardiovascular safety in healthy volunteers.

Conditions

Healthy

Keywords

electrocardiographic safety; pharmacokinetics

Interventions

Prucalopride DRUG

Placebo OTHER

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Movetis: lead

MeSH Terms

Interventions

prucalopride

Study Design

• Study Type: interventional
• Phase: phase 1
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 18, 2008
• First Posted: November 19, 2008
• Last Updated: November 21, 2008

Record last verified: 2008-11