Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-24 @ 12:22 PM
NCT ID:
NCT05303961
Eligibility Criteria:
Inclusion Criteria:
1. 19 years to 45 years (Healthy male Korean)
2. Body weight of 55 to 90kg; and BMI of 18.0 to 27.0 kg/m2
3. Subject who voluntarily agrees to participate in this study and has given a written informed consent, after fully understanding the detailed explanation of this study
Exclusion Criteria:
1. Subject with a disease history of any clinically significant condition as below.
\- Liver, Kidney, nervous system, immune system, respiratory system, endocrine system, tumor, cardiovascular disease or mental illness (mood disorder or obsessive-compulsive disorder etc.) etc.
2. Subject with a history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (except simple appendicectomy or hernia surgery) that may affect the absorption of the study drug
3. Subject with a history of clinically significant hypersensitivity or hypersensitivity reactions to drugs (aspirin, antibiotics, etc.)
4. Serum ALT(SGPT)/AST(SGOT) \>1.5×institutional upper limit normal (ULN)
5. eGFR\< 90mL/min/1.73m2
6. Systolic blood pressure \<100 mmHg or \>160 mmHg
7. Diastolic blood pressure \<60 mmHg or \>100 mmHg
8. Inadequate cardiac function confirmed by 12-lead ECG findings at screening as followings:
* QTcF \> 430msec (males)
* PR interval \> 200msec or \< 110msec
* QRS complex \> 120msec
* Evidence of 2nd- or 3rd-degree atrioventricular (AV) block
* Pathologic Q waves (defined as Q-wave \> 40msec or depth \> 0.5mV)
* Evidence of ventricular preexicitation, left bundle branch block (LBBB), right bundle branch block (RBBB, Incomplete RBBB)
9. Subject with risk factors for Torsade de pointes such as long QT syndrome, family history of sudden death, heart failure, hypokalemia, and arrhythmias
10. Subject with a history of drug abuse within 60 days prior to screening or who is positive for drugs of abuse in urine tests at screening
11. Subject who received any drugs such as
* Prescription drug or herbal medicine within 14 days prior to the first administration of the investigational products
* Over the counter (OTC) or vitamin within 7 days prior to the first administration of the investigational products
12. Subject who received other investigational products within 90 days prior to the first administration of the investigational products
13. Subject who have donated whole blood within 60 days prior to the first administration of the investigational products, or donated component blood or have received blood transfusion within 30 days prior to the first administration of the investigational products
14. Subject who continuously drink alcohol (more than 21 units/week, 1 unit = 10 g of pure alcohol) or cannot abstain from alcohol during the study period
15. Subject with history of smoking within 90 days prior to the first administration of the investigational products
16. Subject who cannot prohibit grapefruit/ caffeine-containing foods during the study period from 3 days before the first administration of the investigational products
17. Man of reproductive potential not willing to use contraceptive measures during the study period
18. Subject not eligible for study participation in the opinion of the investigator
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
19 Years
Maximum Age:
45 Years
Study:
NCT05303961
Study Brief:
Protocol Section:
NCT05303961