HealthyPhase 1NCT02816853

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

A Phase 1 study testing Domperidone and Moxifloxacin in people with Healthy, run by Janssen Research & Development, LLC at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Domperidone and Moxifloxacin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 44 participants
Where: 1 siteChina
Study dates: May 2016to Aug 2016
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

Study site
Beijing

Other trials in China

About this study

Official 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

Conditions: Healthy
Being tested: Domperidone, Placebo, Moxifloxacin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DomperidoneDrug
Domperidone 10 mg or 20 mg tablets will be administered.
PlaceboDrug
Matching placebo will be administered.
MoxifloxacinDrug
Moxifloxacin 400 mg tablet will be administered.

Study groups in NCT02816853
Study group	Role	What they receive
Sequence 1	Experimental	Participants will be randomly assigned to 1 of 4 treatment sequence groups based on a computer generated randomization schedule and will receive the following 4 treatments in order specified by randomization: Treatment A (1 domperidone 10 mg tablet 3 times a day (tid) + 1 placebo tablet tid on Days 1 to 3 and a single dose of 1 domperidone 10 mg tablet +1 placebo tablet in the morning of Day 4), Treatment B (2 domperidone 10 mg tablets tid on Days 1 to 3 and a single dose of 2 domperidone 10 mg tablets in the morning of Day 4), Treatment C (2 placebo tablets tid on Days 1 to 3 and a single dose of 2 placebo tablets in the morning of Day 4) and Treatment D (2 placebo tablets tid on Days 1 to 3 and a single dose of 2 placebo tablets + 1 moxifloxacin 400 mg tablet in the morning of Day 4). Receives: Drug: Domperidone; Drug: Placebo; Drug: Moxifloxacin
Sequence 2	Experimental	Participants will be randomly assigned to 1 of 4 treatment sequence groups based on a computer generated randomization schedule and will receive the following 4 treatments in order specified by randomization: Treatment A (1 domperidone 10 mg tablet 3 times a day (tid) + 1 placebo tablet tid on Days 1 to 3 and a single dose of 1 domperidone 10 mg tablet +1 placebo tablet in the morning of Day 4), Treatment B (2 domperidone 10 mg tablets tid on Days 1 to 3 and a single dose of 2 domperidone 10 mg tablets in the morning of Day 4), Treatment C (2 placebo tablets tid on Days 1 to 3 and a single dose of 2 placebo tablets in the morning of Day 4) and Treatment D (2 placebo tablets tid on Days 1 to 3 and a single dose of 2 placebo tablets + 1 moxifloxacin 400 mg tablet in the morning of Day 4). Receives: Drug: Domperidone; Drug: Placebo; Drug: Moxifloxacin
Sequence 3	Experimental	Participants will be randomly assigned to 1 of 4 treatment sequence groups based on a computer generated randomization schedule and will receive the following 4 treatments in order specified by randomization: Treatment A (1 domperidone 10 mg tablet 3 times a day (tid) + 1 placebo tablet tid on Days 1 to 3 and a single dose of 1 domperidone 10 mg tablet +1 placebo tablet in the morning of Day 4), Treatment B (2 domperidone 10 mg tablets tid on Days 1 to 3 and a single dose of 2 domperidone 10 mg tablets in the morning of Day 4), Treatment C (2 placebo tablets tid on Days 1 to 3 and a single dose of 2 placebo tablets in the morning of Day 4) and Treatment D (2 placebo tablets tid on Days 1 to 3 and a single dose of 2 placebo tablets + 1 moxifloxacin 400 mg tablet in the morning of Day 4). Receives: Drug: Domperidone; Drug: Placebo; Drug: Moxifloxacin
Sequence 4	Experimental	Participants will be randomly assigned to 1 of 4 treatment sequence groups based on a computer generated randomization schedule and will receive the following 4 treatments in order specified by randomization: Treatment A (1 domperidone 10 mg tablet 3 times a day (tid) + 1 placebo tablet tid on Days 1 to 3 and a single dose of 1 domperidone 10 mg tablet +1 placebo tablet in the morning of Day 4), Treatment B (2 domperidone 10 mg tablets tid on Days 1 to 3 and a single dose of 2 domperidone 10 mg tablets in the morning of Day 4), Treatment C (2 placebo tablets tid on Days 1 to 3 and a single dose of 2 placebo tablets in the morning of Day 4) and Treatment D (2 placebo tablets tid on Days 1 to 3 and a single dose of 2 placebo tablets + 1 moxifloxacin 400 mg tablet in the morning of Day 4). Receives: Drug: Domperidone; Drug: Placebo; Drug: Moxifloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in QTc Interval Based on Fridericia Correction Method (QTcF)
The QT interval corrected for heart rate (QTc interval) using Fridericia method will be measured by electrocardiograms (ECG).
Measured: Baseline, Day 1 and Day 4

Secondary outcomes (9)

Change From Baseline in QTc Interval Based on Study-Specific Power Correction (QTcP)
The QT interval corrected for heart rate (QTc interval) using study-specific power correction method will be measured by electrocardiograms (ECG).
Measured: Baseline, Day 1 and Day 4
Change From Baseline in QTc Interval Based on Bazett Method (QTcB)
The QT interval corrected for heart rate (QTc interval) using Bazett method will be measured by electrocardiograms (ECG).
Measured: Baseline, Day 1 and Day 4
Change From Baseline in HR, QRS and PR Intervals
The HR, QRS, and PR Intervals will be measured by ECG.
Measured: Baseline, Day 4
Maximum Observed Plasma Concentration
The Cmax is the maximum observed plasma concentration.
Measured: Day 1
Time to Reach the Maximum Plasma Concentration (Tmax)
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Measured: Day 1 and Day 4 (Predose up to 5 hours post dose)
Area Under the Plasma Concentration-Time Curve During the First Dosing Interval (AUCtau)
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.
Measured: Day 1 and Day 4 (Predose up to 5 hours post dose)
Maximum Plasma Concentration at Steady State (Cmax,ss)
The Cmax,ss is the maximum observed plasma concentration at steady state.
Measured: Day 4 (Predose up to 5 hours post dose)
Minimum Plasma Concentration at Steady State (Cmin,ss)
The Cmin,ss is the minimum observed plasma concentration at steady state.
Measured: Day 4 (Predose up to 5 hours post dose)
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) as a Measure of Safety and Tolerability
Measured: Up to End of Study (4 to 10 days after last study drug administration)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2016Aug 2016

First posted29 Jun 2016 (estimated)
Study startMay 2016
Primary completionAug 2016
Study completionAug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02816853
Sponsor's protocol ID: CR108170
Other IDs: R033812DYP1002
Status last verified: Jan 2025
First submitted: 3 Jun 2016
Last updated: 3 Feb 2025
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT02816853
Acronym / sponsor ID: CR108170
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: May 2016
Primary completion: Aug 2016 (actual)
Study completion: Aug 2016 (actual)
First posted: 29 Jun 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Sequence 1	Experimental	Drug: Domperidone, Drug: Placebo, Drug: MoxifloxacinParticipants will be randomly assigned to 1 of 4 treatment sequence groups based on a computer generated randomization schedule and will receive the following 4 treatments in order specified by randomization: Treatment A (1 domperidone 10 mg tablet 3 times a day (tid) + 1 placebo tablet tid on Days 1 to 3 and a single dose of 1 domperidone 10 mg tablet +1 placebo tablet in the morning of Day 4), Treatment B (2 domperidone 10 mg tablets tid on Days 1 to 3 and a single dose of 2 domperidone 10 mg tablets in the morning of Day 4), Treatment C (2 placebo tablets tid on Days 1 to 3 and a single dose of 2 placebo tablets in the morning of Day 4) and Treatment D (2 placebo tablets tid on Days 1 to 3 and a single dose of 2 placebo tablets + 1 moxifloxacin 400 mg tablet in the morning of Day 4).
Sequence 2	Experimental	Drug: Domperidone, Drug: Placebo, Drug: MoxifloxacinParticipants will be randomly assigned to 1 of 4 treatment sequence groups based on a computer generated randomization schedule and will receive the following 4 treatments in order specified by randomization: Treatment A (1 domperidone 10 mg tablet 3 times a day (tid) + 1 placebo tablet tid on Days 1 to 3 and a single dose of 1 domperidone 10 mg tablet +1 placebo tablet in the morning of Day 4), Treatment B (2 domperidone 10 mg tablets tid on Days 1 to 3 and a single dose of 2 domperidone 10 mg tablets in the morning of Day 4), Treatment C (2 placebo tablets tid on Days 1 to 3 and a single dose of 2 placebo tablets in the morning of Day 4) and Treatment D (2 placebo tablets tid on Days 1 to 3 and a single dose of 2 placebo tablets + 1 moxifloxacin 400 mg tablet in the morning of Day 4).
Sequence 3	Experimental	Drug: Domperidone, Drug: Placebo, Drug: MoxifloxacinParticipants will be randomly assigned to 1 of 4 treatment sequence groups based on a computer generated randomization schedule and will receive the following 4 treatments in order specified by randomization: Treatment A (1 domperidone 10 mg tablet 3 times a day (tid) + 1 placebo tablet tid on Days 1 to 3 and a single dose of 1 domperidone 10 mg tablet +1 placebo tablet in the morning of Day 4), Treatment B (2 domperidone 10 mg tablets tid on Days 1 to 3 and a single dose of 2 domperidone 10 mg tablets in the morning of Day 4), Treatment C (2 placebo tablets tid on Days 1 to 3 and a single dose of 2 placebo tablets in the morning of Day 4) and Treatment D (2 placebo tablets tid on Days 1 to 3 and a single dose of 2 placebo tablets + 1 moxifloxacin 400 mg tablet in the morning of Day 4).
Sequence 4	Experimental	Drug: Domperidone, Drug: Placebo, Drug: MoxifloxacinParticipants will be randomly assigned to 1 of 4 treatment sequence groups based on a computer generated randomization schedule and will receive the following 4 treatments in order specified by randomization: Treatment A (1 domperidone 10 mg tablet 3 times a day (tid) + 1 placebo tablet tid on Days 1 to 3 and a single dose of 1 domperidone 10 mg tablet +1 placebo tablet in the morning of Day 4), Treatment B (2 domperidone 10 mg tablets tid on Days 1 to 3 and a single dose of 2 domperidone 10 mg tablets in the morning of Day 4), Treatment C (2 placebo tablets tid on Days 1 to 3 and a single dose of 2 placebo tablets in the morning of Day 4) and Treatment D (2 placebo tablets tid on Days 1 to 3 and a single dose of 2 placebo tablets + 1 moxifloxacin 400 mg tablet in the morning of Day 4).

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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)

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DomperidoneDomperidone 10 mg or 20 mg tablets will be administered.	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4
PlaceboMatching placebo will be administered.	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4
MoxifloxacinMoxifloxacin 400 mg tablet will be administered.	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4

Primary outcome

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).

9 secondary outcomes

Change From Baseline in QTc Interval Based on Study-Specific Power Correction (QTcP)
Time frame: Baseline, Day 1 and Day 4
Change From Baseline in QTc Interval Based on Bazett Method (QTcB)
Time frame: Baseline, Day 1 and Day 4
Change From Baseline in HR, QRS and PR Intervals
Time frame: Baseline, Day 4
Maximum Observed Plasma Concentration
Time frame: Day 1
Time to Reach the Maximum Plasma Concentration (Tmax)
Time frame: Day 1 and Day 4 (Predose up to 5 hours post dose)
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)
Maximum Plasma Concentration at Steady State (Cmax,ss)
Time frame: Day 4 (Predose up to 5 hours post dose)
Minimum Plasma Concentration at Steady State (Cmin,ss)
Time frame: Day 4 (Predose up to 5 hours post dose)
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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janssen Research & Development, LLC Clinical Trial study director

Janssen Research & Development, LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Domperidone and Moxifloxacin in people with Healthy, run by Janssen Research & Development, LLC at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in QTc Interval Based on Fridericia Correction Method (QTcF) (time frame: Baseline, Day 1 and Day 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02816853.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.