A Trial in Healthy Volunteers, to Evaluate the Tolerability and Cardiac Safety of Prucalopride

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00488215
Recruitment Status : Completed
First Posted : June 20, 2007
Last Update Posted : May 29, 2008
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Brief Summary:
An escalating dose of prucalopride up to a maximum of 20 mg was given once daily to 32 healthy volunteers to determine safety at the maximum tolerable dose or at 20 mg.

Condition or disease Intervention/treatment Phase
Constipation Drug: prucalopride Other: Placebo Phase 1

Detailed Description:

This is a single-centre, double-blind, placebo-controlled, cross-over trial in 32 healthy volunteers with two sessions (I and II). Each session consists of a run-in day for baseline assessments, 13 treatment days and 5 additional days for assessments. Subjects will be randomized to start with either the prucalopride or placebo session.

Between the 2 sessions, there will be a washout period of 14 to 21 days, to avoid any carry-over effect.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: A Double-Blind, Placebo-Controlled, 2-Way Cross-Over Trial in Healthy Volunteers, to Evaluate the Pharmacokinetics, Tolerability and Cardiac Safety of Oral Prucalopride at Steady State, After up-Titration to a Maximum of 20 mg.
Study Start Date : January 2000
Primary Completion Date : March 2000
Study Completion Date : March 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Drug: prucalopride
The dose will be consecutively escalated in 2 mg steps per day, starting from 2 mg up to 20 mg once daily or until severe drug-related adverse events occur (= individual maximum tolerable dose, on decision of the subject and/or investigator).
Other Name: Resolor
Placebo Comparator: 2
Other: Placebo
During the placebo session, the number of placebo tablets will be consecutively escalated in an identical way as described for prucalopride. This means 1 tablet more every day, up to 10 tablets.

Primary Outcome Measures :
  1. The exploration whether the maximum tolerable dose (MTD, defined as the highest dose not causing severe drug-related adverse events in > 50 % of the subjects) is achieved between 0 and 20 mg prucalopride. [ Time Frame: 26 days ]

Secondary Outcome Measures :
  1. The documentation of laboratory and cardiovascular safety (vital signs, ECG, Holter monitoring) at the MTD or at 20 mg. [ Time Frame: 26 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Aged between 18 and 45 years, extremes included.
  2. Subject has a normal weight as defined by a Quetelet Index range of 18 - 30 kg/m2, extremes included.
  3. Informed consent form signed and dated, prior to screening.
  4. Healthy on the basis of a pre-trial physical examination, medical history, anamnesis, electrocardiogram, 24 hour Holter monitoring and the results of blood biochemistry and haematology tests and a urinalysis carried out in 3 weeks preceding randomization.

Exclusion Criteria:

  1. History or suspicion of alcohol, barbiturate, amphetamine or narcotic abuse.
  2. Smoking more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 6 months prior to selection.
  3. History of cardiac arrhythmia's, bronchospastic or cardiovascular disease (e.g. ischemic heart disease or cerebrovascular accident), diabetes mellitus, thyrotoxicosis, Parkinsonism, drug allergy.
  4. Presence of prolonged QTc (Bazett) on ECG at screening (QTc > 450 msec in male subjects, QTc > 470 msec in female subjects).
  5. Use of concomitant medication, except for oral contraceptives and paracetamol. All other medication must have been stopped at least 14 days before the first dose.
  6. Participation in an investigational drug trial in 30 days prior to the first visit.
  7. Donation of blood in the 60 days preceding the first visit.
  8. Pregnancy (as confirmed by a HCG test during screening and at day 0 of each treatment session) or breast-feeding female.
  9. Subjects with positive results for HIV, hepatitis B or C at screening.
  10. Female subjects of childbearing potential without adequate contraceptive protection during the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00488215

Sponsors and Collaborators
Principal Investigator: M J Boyce, M.D. Central Middlesex Hospital, London

Responsible Party: Renate Specht Gryp, Movetis Identifier: NCT00488215     History of Changes
Other Study ID Numbers: PRU-GBR-10
First Posted: June 20, 2007    Key Record Dates
Last Update Posted: May 29, 2008
Last Verified: June 2007

Keywords provided by Movetis:
cardiovascular safety

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms