Clinical Study to Evaluate Effect on QT/QTc Interval After Multiple Dose of Celecoxib

Qt Interval, Variation in Clinical Trial

Official title:

A Randomized, Open-label, Negative and Positive Control, Crossover Clinical Study to Evaluate Effect on QT/QTc Interval After Multiple Dose of Celecoxib in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03822520
• Other study ID #: 2016-11-053
• Status: Completed
• Phase: Phase 1
• Start date: June 30, 2017
• Est. completion date: May 25, 2018

Study information

• Verified date: January 2019
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is conducted to evaluate effect on QT/QTc Interval after multiple dose of celecoxib among healthy adult volunteers. It is randomized, open-label, negative and postive control, and crossover study. Volunteers will be mainly checked up through ECG to find out changes of QT/QTc interval during the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 25, 2018
• Est. primary completion date: May 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy adults between 19-year-old and 40-year-old during the screening day

• BMI between 19 kg/m² and 30 kg/m² during the screening day

• Be able to give an informed consent form after understanding for reasonable explanation of clinical trial's purpose, contents and characteristics of clinical drugs

• Wiling to participate whole clinical trial periods

Exclusion Criteria:

• Person who is able to clinically affect to the study through ECG result during the screening day

• Has critical issue for Torsade de points from heart failure, hypopotassemia, arrhythmia etc., or family history for long QT syndrome, sudden cardiac death.

• Was suffered, or is suffering from like liver, kidney, digestive system, circulatory system, respiratory system, endocrine system(except diabetes), musculoskeletal, neuropsychiatry, or hemato-oncology etc., which is able to effect on clinical study

• Has allergy which is required the treatment or hypersensitive from drugs such as aspirin, anti-biotics, anti-depressants, etc.

• Was administered any drug of other clinical study within 90 days from the randomization day.

• Donated whole blood within 60days or apheresis within 30 days from the randomization day.

• Took any medicine or oriental medicine within 2 weeks, or general pharmaceuticals within 7 days from the randomization day. (For general pharmaceuticals circumstances, PI could decide whether he/she is suitable for the study)

• No intention to take contraceptive which is approved as clinical way, or is planning on giving their sperm or egg during the whole clinical trial.

• Average alcohol consumption per week: >140g

• Average smoking per day: >20

• Average grapefruit juice consumption per day: >4 glasses

• systolic blood pressure <100 mmHg or >150 mmHg, or diastolic pressure <70 mmHg or >100mmHg

• Over 2 times from the maximum reference interval of AST and ALT levels in the blood.

• eGFR by MDRD from creatinine in the blood is less than 30 mL/min.

• doesn't show negative reaction from HIV Test, B hepatitis test, or C hepatitis test

• For woman, doesn't show negative reaction from pregnancy test

• PI decides the person is not suitable to participate the clinical study with other reasons.

Related Conditions & MeSH terms

• Qt Interval, Variation in

Intervention

Drug:
• Celecoxib
Celecoxib 400mg capsule
• Moxifloxacin
Moxifloxacin 400mg tablet

Other:
• Water
Pure water 150ml

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in QTc interval, read manually	which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.	-1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day
Secondary	Change in QTc , measured automatically	which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.	-1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day
Secondary	ventricular rate, measured automatically	which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.	-1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day
Secondary	PR duration, measured automatically	which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.	-1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day
Secondary	RR duration, measured automatically	which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.	-1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day
Secondary	QRS duration, measured automatically	which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.	-1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day
Secondary	Area under the curve within a dosing interval at steady state	which is analyzed at the date of final administration of celecoxib	0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day6)
Secondary	Maximum concentration at steady state	which is analyzed at the date of final administration of celecoxib	0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day6)
Secondary	Time to maximum concentration at steady state	which is analyzed at the date of final administration of celecoxib	0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day6)
Secondary	Minimum concentration at steady state	which is analyzed at the date of final administration of celecoxib	0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day6)
Secondary	Area under the concentration-time curve time zero to the time of the last quantifiable concentration	which is analyzed at the date of final administration of moxifloxacin	0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day1)
Secondary	Maximum concentration	which is analyzed at the date of final administration of moxifloxacin	0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day1)
Secondary	Time to maximum concentration	which is analyzed at the date of final administration of moxifloxacin	0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day1)
Secondary	Half-life	which is analyzed at the date of final administration of moxifloxacin	0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day1)
Secondary	The apparent clearance	which is analyzed at the date of final administration of moxifloxacin	0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day1)