A Study to Evaluate the Effects of Domperidone on Cardiac Repolarization in Healthy Volunteers
A Randomized, Double-Blind, Placebo- and Positive-Controlled, Single- and Multiple-Dose, 4-Way Crossover Study to Evaluate the Effects of Domperidone on Cardiac Repolarization in Healthy Subjects
3 other identifiers
interventional
44
1 country
1
Brief Summary
The purpose of this study is to assess the effects of single and multiple doses of domperidone on the QTc interval duration in healthy adult volunteers at domperidone doses of 10 mg four times a day (q.i.d.) and 20 mg q.i.d.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Jul 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 16, 2012
CompletedFirst Posted
Study publicly available on registry
July 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedJune 24, 2013
June 1, 2013
4 months
July 16, 2012
June 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The change from baseline in QTc intervals on Day 1
Baseline, 5 hours
The change from baseline in QTc intervals on Day 4
Baseline, 5 hours
Secondary Outcomes (4)
The plasma concentrations of domperidone
9 time points on Day 1
The plasma concentrations of domperidone
9 time points on Day 4
The plasma concentrations of moxifloxacin
9 time points on Day 1
The plasma concentrations of moxifloxacin
9 time points on Day 4
Study Arms (4)
Sequence group ADBC
EXPERIMENTALTreatment A: domperidone 10 mg; Treatment B: domperidone 20 mg; Treatment C: placebo; Treatment D: moxifloxacin.
Sequence group BACD
EXPERIMENTALTreatment A: domperidone 10 mg; Treatment B: domperidone 20 mg; Treatment C: placebo; Treatment D: moxifloxacin.
Sequence group CBDA
EXPERIMENTALTreatment A: domperidone 10 mg; Treatment B: domperidone 20 mg; Treatment C: placebo; Treatment D: moxifloxacin.
Sequence group DCAB
EXPERIMENTALTreatment A: domperidone 10 mg; Treatment B: domperidone 20 mg; Treatment C: placebo; Treatment D: moxifloxacin.
Interventions
1 domperidone 10 mg capsule four times a day (q.i.d.) + 1 domperidone placebo capsule q.i.d. on Days 1 to 3 and a single dose on Day 4 (13 doses in total), and 1 moxifloxacin placebo capsule in the morning of Day 1.
2 domperidone 10 mg capsules four times a day (q.i.d.) on Days 1 to 3 and a single dose on Day 4 (13 doses in total), and 1 moxifloxacin placebo capsule in the morning of Day 1.
2 domperidone placebo capsules four times a day (q.i.d.) on Days 1 to 3 and a single dose on Day 4 (13 doses in total), and 1 moxifloxacin placebo capsule in the morning of Day 1.
2 domperidone placebo capsules four times a day (q.i.d.) on Days 1 to 3 and a single dose on Day 4 (13 doses in total), and 1 moxifloxacin 400 mg capsule in the morning of Day 1.
Eligibility Criteria
You may qualify if:
- If a woman, must be postmenopausal, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control
- If a woman, must have a negative serum beta human chorionic gonadotropin (hCG) pregnancy test at screening; and a negative urine pregnancy test on Day -1 of each treatment period
- Body mass index (BMI; weight \[kg\]/height2 \[m\]2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
- Blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
- An electrocardiogram (ECG) consistent with normal cardiac conduction and function
You may not qualify if:
- History of risk factors for cardiac diseases
- Laboratorial tests with clinically significant abnormal values
- Clinically significant abnormal physical examination, vital signs or electrocardiogram (ECG) at screening
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol within 14 days before the first dose of the study drug
- History of or current clinically significant medical illness, disease, or condition that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Merksem, Belgium
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2012
First Posted
July 18, 2012
Study Start
July 1, 2012
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
June 24, 2013
Record last verified: 2013-06