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

Primary Purpose

Constipation

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

prucalopride

moxifloxacin

placebo

About this trial

This is an interventional treatment trial for Constipation focused on measuring Prucalopride, safety study

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Main Inclusion Criteria:

Healthy volunteers aged between 18 to 50 years.
Body mass index (BMI) between 18 and 30 kg/m2.
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:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Prucalopride

Placebo/moxifloxacin

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00903747

First Posted

May 15, 2009

Last Updated

May 15, 2009

Sponsor

Movetis

1. Study Identification

Unique Protocol Identification Number

NCT00903747

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

May 2009

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Movetis

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Constipation

Keywords

Prucalopride, safety study

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Prucalopride

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo/moxifloxacin

Intervention Type

Drug

Intervention Name(s)

prucalopride

Other Intervention Name(s)

Resolor

Intervention Description

2-10 mg prucalopride

Intervention Type

Drug

Intervention Name(s)

moxifloxacin

Other Intervention Name(s)

Avelox

Intervention Description

400 mg moxifloxacin (Group 2a)

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

placebo (Group 2b)

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Main Inclusion Criteria: Healthy volunteers aged between 18 to 50 years. Body mass index (BMI) between 18 and 30 kg/m2. 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: Abnormal QTcF and/or heart rate/blood pressure values at baseline. Subjects with ECG abnormalities that may interfere with the accurate assessment of the QT interval. Subjects with known cardiovascular disorders. Subjects with known clinically significant arrhythmias. Subjects with risk factors e.g., Torsades de Pointes. Subjects with clinically relevant, abnormal serum electrolytes or complete blood count (CBC) at screening. Female subjects who are lactating or pregnant. Subjects suffering from other significant medical conditions. Subjects with a known allergy or sensitivity to moxifloxacin, or to prucalopride. Subjects with a positive screening test for hepatitis B, hepatitis C, or HIV at screening.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Remi VD Broeck, MD

Organizational Affiliation

Movetis NV

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

21848574

Citation

Mendzelevski B, Ausma J, Chanter DO, Robinson P, Kerstens R, Vandeplassche L, Camm J. Assessment of the cardiac safety of prucalopride in healthy volunteers: a randomized, double-blind, placebo- and positive-controlled thorough QT study. Br J Clin Pharmacol. 2012 Feb;73(2):203-9. doi: 10.1111/j.1365-2125.2011.04088.x.

Results Reference

derived

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

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