Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03822520
Recruitment Status : Completed
First Posted : January 30, 2019
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Jung-Ryul Kim, 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.

Condition or disease Intervention/treatment Phase
Qt Interval, Variation in Drug: Celecoxib Drug: Moxifloxacin Other: Water Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : June 30, 2017
Actual Primary Completion Date : May 25, 2018
Actual Study Completion Date : May 25, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Celecoxib, Moxifloxacin, Water in order
  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
Drug: Celecoxib
Celecoxib 400mg capsule
Other Name: Celebrex

Drug: Moxifloxacin
Moxifloxacin 400mg tablet
Other Name: Avelox

Other: Water
Pure water 150ml

Experimental: Celecoxib, Water, Moxifloxacin in order
  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
Drug: Celecoxib
Celecoxib 400mg capsule
Other Name: Celebrex

Drug: Moxifloxacin
Moxifloxacin 400mg tablet
Other Name: Avelox

Other: Water
Pure water 150ml

Experimental: Moxifloxacin, Water, Celecoxib in order
  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
Drug: Celecoxib
Celecoxib 400mg capsule
Other Name: Celebrex

Drug: Moxifloxacin
Moxifloxacin 400mg tablet
Other Name: Avelox

Other: Water
Pure water 150ml

Experimental: Water, Moxifloxacin, Celecoxib in order
  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
Drug: Celecoxib
Celecoxib 400mg capsule
Other Name: Celebrex

Drug: Moxifloxacin
Moxifloxacin 400mg tablet
Other Name: Avelox

Other: Water
Pure water 150ml




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03822520


Locations
Layout table for location information
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
Layout table for investigator information
Principal Investigator: JUNGRYUL KIM, MD, PhD Samsung Medical Center

Layout table for additonal information
Responsible Party: Jung-Ryul Kim, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03822520     History of Changes
Other Study ID Numbers: 2016-11-053
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Celecoxib
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents