Clinical Study to Evaluate Effect on QT/QTc Interval After Multiple Dose of Celecoxib
Phase 1
Completed
- Conditions
- Qt Interval, Variation in
- Interventions
- Registration Number
- NCT03822520
- Lead Sponsor
- Samsung Medical Center
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Celecoxib, Water, Moxifloxacin in order Water 1. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days Wash-out period (3\~6 days) 2. Intervention Pure water: Water 150ml by mouth without any drug, once for one day Wash-out period (3\~6 days) 3. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day Celecoxib, Moxifloxacin, Water in order Water 1. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days Wash-out period (3\~6 days) 2. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day Wash-out period (3\~6 days) 3. Intervention Pure water: Water 150ml by mouth without any drug, once for one day Moxifloxacin, Water, Celecoxib in order Water 1. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day Wash-out period (3\~6 days) 2. Intervention Pure water: Water 150ml by mouth without any drug, once for one day Wash-out period (3\~6 days) 3. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days Water, Moxifloxacin, Celecoxib in order Water 1. Intervention Pure water: Water 150ml by mouth without any drug, once for one day Wash-out period (3\~6 days) 2. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day Wash-out period (3\~6 days) 3. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days Celecoxib, Moxifloxacin, Water in order Celecoxib 1. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days Wash-out period (3\~6 days) 2. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day Wash-out period (3\~6 days) 3. Intervention Pure water: Water 150ml by mouth without any drug, once for one day Celecoxib, Moxifloxacin, Water in order Moxifloxacin 1. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days Wash-out period (3\~6 days) 2. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day Wash-out period (3\~6 days) 3. Intervention Pure water: Water 150ml by mouth without any drug, once for one day Celecoxib, Water, Moxifloxacin in order Celecoxib 1. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days Wash-out period (3\~6 days) 2. Intervention Pure water: Water 150ml by mouth without any drug, once for one day Wash-out period (3\~6 days) 3. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day Celecoxib, Water, Moxifloxacin in order Moxifloxacin 1. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days Wash-out period (3\~6 days) 2. Intervention Pure water: Water 150ml by mouth without any drug, once for one day Wash-out period (3\~6 days) 3. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day Moxifloxacin, Water, Celecoxib in order Celecoxib 1. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day Wash-out period (3\~6 days) 2. Intervention Pure water: Water 150ml by mouth without any drug, once for one day Wash-out period (3\~6 days) 3. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days Moxifloxacin, Water, Celecoxib in order Moxifloxacin 1. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day Wash-out period (3\~6 days) 2. Intervention Pure water: Water 150ml by mouth without any drug, once for one day Wash-out period (3\~6 days) 3. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days Water, Moxifloxacin, Celecoxib in order Moxifloxacin 1. Intervention Pure water: Water 150ml by mouth without any drug, once for one day Wash-out period (3\~6 days) 2. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day Wash-out period (3\~6 days) 3. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days Water, Moxifloxacin, Celecoxib in order Celecoxib 1. Intervention Pure water: Water 150ml by mouth without any drug, once for one day Wash-out period (3\~6 days) 2. Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day Wash-out period (3\~6 days) 3. Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days
- Primary Outcome Measures
Name Time Method Change in QTc interval, read manually -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 which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.
- Secondary Outcome Measures
Name Time Method Change in QTc , measured automatically -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 which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.
Half-life 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) which is analyzed at the date of final administration of moxifloxacin
The apparent clearance 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) which is analyzed at the date of final administration of moxifloxacin
PR duration, measured automatically -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 which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.
RR duration, measured automatically -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 which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.
Time to maximum concentration at steady state 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) which is analyzed at the date of final administration of celecoxib
ventricular rate, measured automatically -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 which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.
QRS duration, measured automatically -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 which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers.
Maximum concentration at steady state 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) which is analyzed at the date of final administration of celecoxib
Area under the concentration-time curve time zero to the time of the last quantifiable concentration 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) which is analyzed at the date of final administration of moxifloxacin
Maximum concentration 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) which is analyzed at the date of final administration of moxifloxacin
Time to maximum concentration 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) which is analyzed at the date of final administration of moxifloxacin
Area under the curve within a dosing interval at steady state 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) which is analyzed at the date of final administration of celecoxib
Minimum concentration at steady state 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) which is analyzed at the date of final administration of celecoxib
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of