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

NCT03822520 | Completed Phase 1

• 1 other identifier: 2016-11-053
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Qt Interval, Variation in

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• 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

• 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

• 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

• 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

• 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

Study Arms (4)

Celecoxib, Moxifloxacin, Water in order

EXPERIMENTAL

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; Drug: Moxifloxacin; Other: Water

Celecoxib, Water, Moxifloxacin in order

EXPERIMENTAL

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; Drug: Moxifloxacin; Other: Water

Moxifloxacin, Water, Celecoxib in order

EXPERIMENTAL

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; Drug: Moxifloxacin; Other: Water

Water, Moxifloxacin, Celecoxib in order

EXPERIMENTAL

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; Drug: Moxifloxacin; Other: Water

Interventions

Celecoxib DRUG

Celecoxib 400mg capsule

Also known as: Celebrex

Celecoxib, Moxifloxacin, Water in order; Celecoxib, Water, Moxifloxacin in order; Moxifloxacin, Water, Celecoxib in order; Water, Moxifloxacin, Celecoxib in order

Moxifloxacin DRUG

Moxifloxacin 400mg tablet

Also known as: Avelox

Celecoxib, Moxifloxacin, Water in order; Celecoxib, Water, Moxifloxacin in order; Moxifloxacin, Water, Celecoxib in order; Water, Moxifloxacin, Celecoxib in order

Water OTHER

Pure water 150ml

Celecoxib, Moxifloxacin, Water in order; Celecoxib, Water, Moxifloxacin in order; Moxifloxacin, Water, Celecoxib in order; Water, Moxifloxacin, Celecoxib in order

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

• Kim S, Lee H, Ko JW, Kim JR. Effects of Celecoxib on the QTc Interval: A Thorough QT/QTc Study. Clin Ther. 2019 Nov;41(11):2204-2218. doi: 10.1016/j.clinthera.2019.09.004. Epub 2019 Sep 26.

  PMID: 31564512 DERIVED

MeSH Terms

Interventions

Celecoxib; Moxifloxacin; Water

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• JUNGRYUL KIM, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: January 30, 2019
• Study Start: June 30, 2017
• Primary Completion: May 25, 2018
• Study Completion: May 25, 2018
• Last Updated: January 30, 2019

Record last verified: 2019-01

Locations

KR (1)