Clinical trial NCT02816853: Study to Evaluate the Effects of Domperidone on Cardiac Repolarization in Chinese Healthy Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2016-06-29
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in QTc Interval Based on Fridericia Correction Method (QTcF)
timeFrame: Baseline, Day 1 and Day 4
Secondary outcomes:
measure: Change From Baseline in QTc Interval Based on Study-Specific Power Correction (QTcP)
timeFrame: Baseline, Day 1 and Day 4
measure: Change From Baseline in QTc Interval Based on Bazett Method (QTcB)
timeFrame: Baseline, Day 1 and Day 4
measure: Change From Baseline in HR, QRS and PR Intervals
timeFrame: Baseline, Day 4
measure: Maximum Observed Plasma Concentration
timeFrame: Day 1
measure: Time to Reach the Maximum Plasma Concentration (Tmax)
timeFrame: Day 1 and Day 4 (Predose up to 5 hours post dose)
measure: Area Under the Plasma Concentration-Time Curve During the First Dosing Interval (AUCtau)
timeFrame: Day 1 and Day 4 (Predose up to 5 hours post dose)
measure: Maximum Plasma Concentration at Steady State (Cmax,ss)
timeFrame: Day 4 (Predose up to 5 hours post dose)
measure: Minimum Plasma Concentration at Steady State (Cmin,ss)
timeFrame: Day 4 (Predose up to 5 hours post dose)
measure: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) as a Measure of Safety and Tolerability
timeFrame: Up to End of Study (4 to 10 days after last study drug administration)
Other outcomes:
Locations:
city: Beijing
country: China
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: