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

NCT00488215 | Completed Phase 1

• 1 other identifier: PRU-GBR-10
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Constipation

Keywords

constipation; prucalopride; MTD; cardiovascular safety

Outcome Measures

Primary Outcomes (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.

  26 days

Secondary Outcomes (1)

• The documentation of laboratory and cardiovascular safety (vital signs, ECG, Holter monitoring) at the MTD or at 20 mg.

  26 days

Study Arms (2)

1

ACTIVE COMPARATOR

Prucalopride

Drug: prucalopride

2

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

prucalopride DRUG

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).

Also known as: Resolor

1

Placebo OTHER

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.

2

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, extremes included.
• Subject has a normal weight as defined by a Quetelet Index range of 18 - 30 kg/m2, extremes included.
• Informed consent form signed and dated, prior to screening.
• 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.

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 arrhythmia's, bronchospastic or cardiovascular disease (e.g. ischemic heart disease or cerebrovascular accident), diabetes mellitus, thyrotoxicosis, Parkinsonism, drug allergy.
• Presence of prolonged QTc (Bazett) on ECG at screening (QTc \> 450 msec in male subjects, QTc \> 470 msec in female subjects).
• 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.
• Participation in an investigational drug trial in 30 days prior to the first visit.
• Donation of blood in the 60 days preceding the first visit.
• Pregnancy (as confirmed by a HCG test during screening and at day 0 of each treatment session) or breast-feeding female.
• Subjects with positive results for HIV, hepatitis B or C at screening.
• Female subjects of childbearing potential without adequate contraceptive protection during the trial.

Sponsors & Collaborators

• Movetis: lead

MeSH Terms

Conditions

Constipation

Interventions

prucalopride

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• M J Boyce, M.D.

  Central Middlesex Hospital, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 19, 2007
• First Posted: June 20, 2007
• Study Start: January 1, 2000
• Primary Completion: March 1, 2000
• Study Completion: March 1, 2000
• Last Updated: May 29, 2008

Record last verified: 2007-06