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

Samsung Medical Center

Status and phase: Completed; Phase 1

Conditions: Qt Interval, Variation in

Treatments: Drug: Moxifloxacin; Other: Water; Drug: Celecoxib

Study type: Interventional

Funder types: Other

Identifiers

NCT03822520

2016-11-053

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 19 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

28 participants in 4 patient groups

Celecoxib, Moxifloxacin, Water in order

Experimental group

Description:

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

Treatment:

Drug: Celecoxib

Other: Water

Drug: Moxifloxacin

Celecoxib, Water, Moxifloxacin in order

Experimental group

Description:

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

Treatment:

Drug: Celecoxib

Other: Water

Drug: Moxifloxacin

Moxifloxacin, Water, Celecoxib in order

Experimental group

Description:

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

Treatment:

Drug: Celecoxib

Other: Water

Drug: Moxifloxacin

Water, Moxifloxacin, Celecoxib in order

Experimental group

Description:

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

Treatment:

Drug: Celecoxib

Other: Water

Drug: Moxifloxacin