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Completed

NCT Number: NCT03822520

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

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.

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Key information

Conditions

Qt Interval, Variation in

Age range

19 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Samsung Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Celecoxib

Drug

Celecoxib 400mg capsule

Other names: Celebrex

moxifloxacin

Drug

Moxifloxacin 400mg tablet

Other names: Avelox

Water

Other

Pure water 150ml

Primary outcomes

  1. Change in QTc interval, read manually

    Time frame: -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 outcomes

  1. Change in QTc , measured automatically

    Time frame: -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.

  2. ventricular rate, measured automatically

    Time frame: -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.

  3. PR duration, measured automatically

    Time frame: -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.

  4. RR duration, measured automatically

    Time frame: -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.

  5. QRS duration, measured automatically

    Time frame: -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.

  6. Area under the curve within a dosing interval at steady state

    Time frame: 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

  7. Maximum concentration at steady state

    Time frame: 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

  8. Time to maximum concentration at steady state

    Time frame: 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

  9. Minimum concentration at steady state

    Time frame: 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

  10. Area under the concentration-time curve time zero to the time of the last quantifiable concentration

    Time frame: 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

  11. Maximum concentration

    Time frame: 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

  12. Time to maximum concentration

    Time frame: 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

  13. Half-life

    Time frame: 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

  14. The apparent clearance

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 30, 2019
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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