COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Thorough Corrected QT Interval (QTc) Study To Evaluate Possible Effects of Prucalopride on ECG Parameters

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: NCT00903747
Recruitment Status : Completed
First Posted : May 18, 2009
Last Update Posted : May 18, 2009
Information provided by:

Brief Summary:

This is a 2-arm, parallel-group active- and placebo-controlled, double-blind randomised study, stratified by gender and with a hybrid crossover group design, to compare treatment with prucalopride 2 mg/day (intended therapeutic dose) and prucalopride 10 mg/day (supratherapeutic dose) with placebo. A single oral dose of 400 mg moxifloxacin is included as a positive control in terms of the effect on cardiac repolarisation.

Study hypothesis:

Treatment with therapeutic (2 mg) or supratherapeutic (10 mg) doses of prucalopride in healthy male and female volunteers will not increase QTc interval compared to placebo.

Condition or disease Intervention/treatment Phase
Constipation Drug: prucalopride Drug: moxifloxacin Drug: placebo Phase 1

Detailed Description:

A total number of 120 healthy subjects (with an approximate 1:1 female:male ratio) are planned to be randomised.

Day 1: a baseline ECG profile. Day 1: Group 1 will receive prucalopride, Group 2a will receive moxifloxacin, and Group 2b will receive placebo.

On Day 5 (steady-state level is reached), a full ECG assessment day will be performed, enabling the comparison of prucalopride 2 mg with placebo.

Subsequently, the number of tablets will be escalated in all groups (blinded) with 1 tablet a day up to 5 tablets.

On Day 13 (steady state for the supratherapeutic dose level of 10 mg of prucalopride) another ECG assessment day will be performed, enabling a comparison of prucalopride 10 mg with placebo.

Group 2b will receive a single dose of moxifloxacin on Day 15. All subjects will be discharged on Day 16. Subjects will remain in the CRU throughout the treatment period.

All subjects will return for a follow-up visit on Day 30 (± 1 week) (approximately 14 days after the last dose).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I Thorough QT/QTc Study To Evaluate The Effect of Therapeutic and Supratherapeutic Multiple Doses of Prucalopride on Cardiac Repolarisation in Healthy Male and Female Volunteers
Study Start Date : January 2009
Actual Primary Completion Date : April 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Drug: prucalopride
2-10 mg prucalopride
Other Name: Resolor

Placebo Comparator: 2
Drug: moxifloxacin
400 mg moxifloxacin (Group 2a)
Other Name: Avelox

Drug: placebo
placebo (Group 2b)

Primary Outcome Measures :
  1. Treatment with therapeutic (2 mg) or supratherapeutic (10 mg) doses of prucalopride in healthy male and female volunteers does not increase QTc interval compared to placebo. [ Time Frame: January to April 2009 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Main Inclusion Criteria:

  1. Healthy volunteers aged between 18 to 50 years.
  2. Body mass index (BMI) between 18 and 30 kg/m2.
  3. Female subjects must:

    • be of childbearing potential with a negative serum β-human chorionic gonadotropin (β-HCG) test at screening, and be willing and able to use medically acceptable double barrier methods of birth control, throughout the whole study; or
    • be postmenopausal; or
    • have received surgical sterilisation at least 6 months before screening; AND
    • females must not be receiving hormone replacement therapy (HRT).

Main exclusion Criteria:

  1. Abnormal QTcF and/or heart rate/blood pressure values at baseline.
  2. Subjects with ECG abnormalities that may interfere with the accurate assessment of the QT interval.
  3. Subjects with known cardiovascular disorders.
  4. Subjects with known clinically significant arrhythmias.
  5. Subjects with risk factors e.g., Torsades de Pointes.
  6. Subjects with clinically relevant, abnormal serum electrolytes or complete blood count (CBC) at screening.
  7. Female subjects who are lactating or pregnant.
  8. Subjects suffering from other significant medical conditions.
  9. Subjects with a known allergy or sensitivity to moxifloxacin, or to prucalopride.
  10. Subjects with a positive screening test for hepatitis B, hepatitis C, or HIV at screening.

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): NCT00903747

Sponsors and Collaborators
Layout table for investigator information
Study Director: Remi VD Broeck, MD Movetis NV
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Remi Van Den Broeck, Movetis NV Identifier: NCT00903747    
Other Study ID Numbers: M0001-C102
First Posted: May 18, 2009    Key Record Dates
Last Update Posted: May 18, 2009
Last Verified: May 2009
Keywords provided by Movetis:
safety study
Additional relevant MeSH terms:
Layout table for MeSH terms
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin 5-HT4 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents