A Study to Evaluate the Effects of Domperidone on Cardiac Repolarization in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01643889
First received: July 16, 2012
Last updated: June 21, 2013
Last verified: June 2013

July 16, 2012
June 21, 2013
July 2012
November 2012   (final data collection date for primary outcome measure)
  • The change from baseline in QTc intervals on Day 1 [ Time Frame: Baseline, 5 hours ] [ Designated as safety issue: No ]
  • The change from baseline in QTc intervals on Day 4 [ Time Frame: Baseline, 5 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01643889 on ClinicalTrials.gov Archive Site
  • The plasma concentrations of domperidone [ Time Frame: 9 time points on Day 1 ] [ Designated as safety issue: No ]
  • The plasma concentrations of domperidone [ Time Frame: 9 time points on Day 4 ] [ Designated as safety issue: No ]
  • The plasma concentrations of moxifloxacin [ Time Frame: 9 time points on Day 1 ] [ Designated as safety issue: No ]
  • The plasma concentrations of moxifloxacin [ Time Frame: 9 time points on Day 4 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

This is a randomized (the study drug is assigned by chance), placebo- and positive-controlled, double-blind (neither physician nor participant knows the treatment that the participant receives), single-dose and multiple-dose, 4-way crossover (method used to switch participants from one treatment arm to another in a clinical trial) study. A placebo control will be used to evaluate the effect of domperidone on QTc intervals in comparison with placebo. QTc is a measure of time in the heart electrical cycle. Placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial. Moxifloxacin, which is known to prolong QTc intervals, will be used as positive control to establish assay sensitivity. The participants will be randomly assigned to 1 of 4 treatment sequence groups (ADBC, BACD, CBDA, and DCAB) based on a computer-generated randomization schedule and will receive the following 4 treatments in the order specified by the randomization: Treatment A (10 mg domperidone); Treatment B (20 mg domperidone); Treatment C (placebo); Treatment D (moxifloxacin). The study has 3 phases: a screening phase, a double-blind treatment phase (that corresponds to 4 treatment periods), and an assessment period. Each treatment period will last 4 days and will be separated with a washout period (ie, period when receiving no treatment) of 4 to 9 days. The participants will be confined to the clinical testing facility for approximately 5 days in each period. All treatments (A, B, C and D) will be given orally with water. The maximum study duration for a participant will be 74 days.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Healthy
  • Drug: Treatment A (domperidone 10 mg)
    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.
  • Drug: Treatment B (domperidone 20 mg)
    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.
  • Drug: Treatment C (placebo)
    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.
  • Drug: Treatment D (moxifloxacin)
    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.
  • Experimental: Sequence group ADBC
    Treatment A: domperidone 10 mg; Treatment B: domperidone 20 mg; Treatment C: placebo; Treatment D: moxifloxacin.
    Interventions:
    • Drug: Treatment A (domperidone 10 mg)
    • Drug: Treatment B (domperidone 20 mg)
    • Drug: Treatment C (placebo)
    • Drug: Treatment D (moxifloxacin)
  • Experimental: Sequence group BACD
    Treatment A: domperidone 10 mg; Treatment B: domperidone 20 mg; Treatment C: placebo; Treatment D: moxifloxacin.
    Interventions:
    • Drug: Treatment A (domperidone 10 mg)
    • Drug: Treatment B (domperidone 20 mg)
    • Drug: Treatment C (placebo)
    • Drug: Treatment D (moxifloxacin)
  • Experimental: Sequence group CBDA
    Treatment A: domperidone 10 mg; Treatment B: domperidone 20 mg; Treatment C: placebo; Treatment D: moxifloxacin.
    Interventions:
    • Drug: Treatment A (domperidone 10 mg)
    • Drug: Treatment B (domperidone 20 mg)
    • Drug: Treatment C (placebo)
    • Drug: Treatment D (moxifloxacin)
  • Experimental: Sequence group DCAB
    Treatment A: domperidone 10 mg; Treatment B: domperidone 20 mg; Treatment C: placebo; Treatment D: moxifloxacin.
    Interventions:
    • Drug: Treatment A (domperidone 10 mg)
    • Drug: Treatment B (domperidone 20 mg)
    • Drug: Treatment C (placebo)
    • Drug: Treatment D (moxifloxacin)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
November 2012
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01643889
CR100893, DOMDYP1001, 2012-001567-70
Not Provided
Janssen Research & Development, LLC
Janssen Research & Development, LLC
Not Provided
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Janssen Research & Development, LLC
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP