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
Verified date | January 2019 |
Source | Samsung Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center |
Korea, Republic of,
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) |
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