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

This study has been completed.
Sponsor:
Information provided by:
Movetis
ClinicalTrials.gov Identifier:
NCT00903747
First received: May 15, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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 Intervention Phase
Constipation
Drug: prucalopride
Drug: moxifloxacin
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Movetis:

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. [ Time Frame: January to April 2009 ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: January 2009
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Prucalopride
Drug: prucalopride
2-10 mg prucalopride
Other Name: Resolor
Placebo Comparator: 2
Placebo/moxifloxacin
Drug: moxifloxacin
400 mg moxifloxacin (Group 2a)
Other Name: Avelox
Drug: placebo
placebo (Group 2b)
Other Name: 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).

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00903747

Sponsors and Collaborators
Movetis
Investigators
Study Director: Remi VD Broeck, MD Movetis NV
  More Information

No publications provided by Movetis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Remi Van Den Broeck, Movetis NV
ClinicalTrials.gov Identifier: NCT00903747     History of Changes
Other Study ID Numbers: M0001-C102
Study First Received: May 15, 2009
Last Updated: May 15, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Movetis:
Prucalopride
safety study

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 31, 2014