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Completed

NCT Number: NCT02816853

Study to Evaluate the Effects of Domperidone on Cardiac Repolarization in Chinese Healthy Participants

The purpose of this study is to assess the effects of domperidone on the QTc interval duration in Chinese healthy adult participants after multiple domperidone doses of 10 milligram (mg) 3 times a day (tid) and 20 mg tid.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at Screening. If there are abnormalities, they must be consistent with the underlying illness in the study population. This determination must be recorded in the participants source documents and signed by the investigator
  • Participant must be healthy on the basis of clinical laboratory tests performed at Screening. If the results of the serum chemistry panel including liver enzymes, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participants source documents and signed by the investigator
  • A woman, must have been proved to be non-pregnant via a highly sensitive serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at Screening; and a negative urine pregnancy test on Day -1 of each treatment period
  • Due to the lack of adequate reproductive toxicity data, in addition to the user independent highly effective method of contraception, a male or female condom with or without spermicide is required. Male condom and female condom should not be used together (due to risk of failure with friction)
  • Body mass index (BMI; weight [kilogram {kg}]/height^2 [meter {m}]^2) between 18 and 30 kilogram per meter square [kg/m^2] (inclusive), and body weight not less than 50 kilogram (kg)

Exclusion criteria

  • History of or current clinically significant medical illness including cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, gastro-intestinal disease, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
  • Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the study center as deemed appropriate by the investigator
  • Presence of hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia or hypocalcemia
  • Clinically significant abnormal physical examination, vital signs or 12-Lead electrocardiogram (ECG) at Screening or at admission to the study center as deemed appropriate by the investigator
  • Known allergy to the Domperidone or any of the excipients of the formulation

Treatment and study plan

Domperidone

Drug

Domperidone 10 mg or 20 mg tablets will be administered.

Placebo

Drug

Matching placebo will be administered.

moxifloxacin

Drug

Moxifloxacin 400 mg tablet will be administered.

Primary outcomes

  1. Change From Baseline in QTc Interval Based on Fridericia Correction Method (QTcF)

    Time frame: Baseline, Day 1 and Day 4

    The QT interval corrected for heart rate (QTc interval) using Fridericia method will be measured by electrocardiograms (ECG).

Secondary outcomes

  1. Change From Baseline in QTc Interval Based on Study-Specific Power Correction (QTcP)

    Time frame: Baseline, Day 1 and Day 4

    The QT interval corrected for heart rate (QTc interval) using study-specific power correction method will be measured by electrocardiograms (ECG).

  2. Change From Baseline in QTc Interval Based on Bazett Method (QTcB)

    Time frame: Baseline, Day 1 and Day 4

    The QT interval corrected for heart rate (QTc interval) using Bazett method will be measured by electrocardiograms (ECG).

  3. Change From Baseline in HR, QRS and PR Intervals

    Time frame: Baseline, Day 4

    The HR, QRS, and PR Intervals will be measured by ECG.

  4. Maximum Observed Plasma Concentration

    Time frame: Day 1

    The Cmax is the maximum observed plasma concentration.

  5. Time to Reach the Maximum Plasma Concentration (Tmax)

    Time frame: Day 1 and Day 4 (Predose up to 5 hours post dose)

    The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.

  6. Area Under the Plasma Concentration-Time Curve During the First Dosing Interval (AUCtau)

    Time frame: Day 1 and Day 4 (Predose up to 5 hours post dose)

    The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval. It is used to characterize drug absorption.

  7. Maximum Plasma Concentration at Steady State (Cmax,ss)

    Time frame: Day 4 (Predose up to 5 hours post dose)

    The Cmax,ss is the maximum observed plasma concentration at steady state.

  8. Minimum Plasma Concentration at Steady State (Cmin,ss)

    Time frame: Day 4 (Predose up to 5 hours post dose)

    The Cmin,ss is the minimum observed plasma concentration at steady state.

  9. Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) as a Measure of Safety and Tolerability

    Time frame: Up to End of Study (4 to 10 days after last study drug administration)

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

A Randomized, Placebo- and Positive-Controlled, Multiple-Dose, 4-Way Crossover Study to Evaluate the Effects of Domperidone on Cardiac Repolarization in Chinese Healthy Subjects

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 29, 2016
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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