- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00793429
Safety Study of Prucalopride in Healthy Volunteers
November 20, 2008 updated by: Movetis
A Double-Blind, Placebo-Controlled, Two-Way Cross-Over in Healthy Volunteers, to Evaluate the Pharmacokinetics, Tolerability and Cardiac Safety of Prucalopride at Steady-State
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.
Study Overview
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 additional days for followup assessments.
Subjects were randomised to start with either the prucalopride or placebo session.
The prucalopride dose was consecutively escalated in 2 mg steps per day, starting from 2 mg up to 10 mg once daily If a subject did not tolerate the 10- or 8-mg dose, 1 step back in the dosage scheme was allowed, from 10 to 8 mg on Day 6, or from 8 to 6 mg on Day 5. Subjects with intolerance for doses of less than 6 mg, were withdrawn from the study.
Repeated dosing (6, 8 or 10 mg) was continued once daily until Day 8, to achieve steady-state.
During placebo, the number of placebo tablets was consecutively escalated in an identical way as described for prucalopride.
Between the 2 sessions, there was a washout period of 14 to 21 days, to avoid any carry-over effect.
Study Type
Interventional
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 18, 2008
First Submitted That Met QC Criteria
November 18, 2008
First Posted (ESTIMATE)
November 19, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
November 21, 2008
Last Update Submitted That Met QC Criteria
November 20, 2008
Last Verified
November 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GBR-9
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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