Clinical Study to Evaluate Effect on QT/QTc Interval After Multiple Dose of Celecoxib
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Celecoxib, Moxifloxacin, Water in order Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days Wash-out period (3~6 days) Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day Wash-out period (3~6 days) Intervention Pure water: Water 150ml by mouth without any drug, once for one day |
Drug: Celecoxib
Celecoxib 400mg capsule
Other Names:
Drug: Moxifloxacin
Moxifloxacin 400mg tablet
Other Names:
Other: Water
Pure water 150ml
|
| Experimental: Celecoxib, Water, Moxifloxacin in order Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days Wash-out period (3~6 days) Intervention Pure water: Water 150ml by mouth without any drug, once for one day Wash-out period (3~6 days) Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day |
Drug: Celecoxib
Celecoxib 400mg capsule
Other Names:
Drug: Moxifloxacin
Moxifloxacin 400mg tablet
Other Names:
Other: Water
Pure water 150ml
|
| Experimental: Moxifloxacin, Water, Celecoxib in order Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day Wash-out period (3~6 days) Intervention Pure water: Water 150ml by mouth without any drug, once for one day Wash-out period (3~6 days) Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days |
Drug: Celecoxib
Celecoxib 400mg capsule
Other Names:
Drug: Moxifloxacin
Moxifloxacin 400mg tablet
Other Names:
Other: Water
Pure water 150ml
|
| Experimental: Water, Moxifloxacin, Celecoxib in order Intervention Pure water: Water 150ml by mouth without any drug, once for one day Wash-out period (3~6 days) Intervention Moxifloxacin: Moxifloxacin 400 mg tablet and water 150ml by mouth, once for one day Wash-out period (3~6 days) Intervention Celecoxib: Celecoxib 400 mg capsule and water 150ml by mouth, daily for 6days |
Drug: Celecoxib
Celecoxib 400mg capsule
Other Names:
Drug: Moxifloxacin
Moxifloxacin 400mg tablet
Other Names:
Other: Water
Pure water 150ml
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
- 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.
- 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.
- 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
- 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
- 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
- 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
- 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
- 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
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Samsung Medical Center | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Samsung Medical Center
Investigators
- Principal Investigator: JUNGRYUL KIM, MD, PhD, Samsung Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2016-11-053