A Study to Evaluate the Effects of Domperidone on Cardiac Repolarization in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      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.
    

Intervention name(s): Treatment A (domperidone 10 mg); Treatment B (domperidone 20 mg); Treatment C (placebo); Treatment D (moxifloxacin)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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.
Intervention MeSH terms: Moxifloxacin; Domperidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy; Domperidone; Cardiac Repolarization