Constipation Clinical Trial
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
Verified date | May 2009 |
Source | Movetis |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | May 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
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 ß-human chorionic gonadotropin (ß-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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Movetis |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | January to April 2009 | No |
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