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

NCT ID: NCT00903747

Last Updated: 2009-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-05-31

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).

Conditions

Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Prucalopride

Group Type: EXPERIMENTAL

prucalopride

Intervention Type: DRUG

2-10 mg prucalopride

2

Placebo/moxifloxacin

Group Type: PLACEBO_COMPARATOR

moxifloxacin

Intervention Type: DRUG

400 mg moxifloxacin (Group 2a)

placebo

Intervention Type: DRUG

placebo (Group 2b)

Interventions

prucalopride

2-10 mg prucalopride

Intervention Type: DRUG

moxifloxacin

400 mg moxifloxacin (Group 2a)

Intervention Type: DRUG

placebo

placebo (Group 2b)

Intervention Type: DRUG

Other Intervention Names

Resolor; Avelox

Eligibility Criteria

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).

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Movetis

INDUSTRY

Sponsor Role: lead

Responsible Party

Movetis NV

Principal Investigators

Remi VD Broeck, MD

Role: STUDY_DIRECTOR

Movetis NV

References

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.

Reference Type: DERIVED

PMID: 21848574 (View on PubMed)

Other Identifiers

M0001-C102

Identifier Type: -

Identifier Source: org_study_id