Phase I clinical trial to investigate the safety, tolerability and pharmacokinetics of NewGenNafamostat in healthy male subjects
- Conditions
- Certain infectious and parasitic diseases
- Registration Number
- KCT0005647
- Lead Sponsor
- ewGen Therapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 32
1. Healthy adult male aged 19 to 50 years old at the time of screening test
2. A person who weighs more than 55.0 kg and less than 90.0 kg at the time of a screening test and has a BMI of more than 19.0 and less than 30.0 kg
? BMI (kg/m2) = weight (kg) / {height (m)}2
3. A person who decides to participate voluntarily and agrees in writing before the screening test after hearing and fully understanding the detailed description of this clinical trial
4. A person who the investigator has determined to be suitable for this screening test through physical examination, clinical laboratory examination, interview, etc
1. A person who has or has a past history of diseases such as clinically significant hepatobiliary(such as severe liver disorders), kidneys (such as severe neuropathy), nervous systems, immune systems, respiratory systems, endocrine systems, blood and tumors, cardiovascular (heart failure, Torsades de points, etc.) and urinary systems and mental disorders.
2. A person who is hypersensitive or has a history of clinically significant hypersensitivity to Nafamostatmesilate, drugs including the same family, and other drugs (such as aspirin, antibiotics, etc.)
3. A person who has gastrointestinal diseases that may affect the safety and pharmacokinetic evaluation of clinical trial medications (gastric ulcer, gastritis, gastric cramps, gastrointestinal reflux disease, Crohn's disease, etc.) or has a history of related surgery (excluding simple appendectomy and hernia surgery)
4. A person who has the following results in a screening test:
1) A case that blood AST, ALT is >1.5 times the normal range upper limit
2) A case that total bilirubin is >1.5 times the normal range upper limit.
3) A case that blood CPK is >1.5 times the normal range upper limit
4) A case that eGFR (estimated Glomerular Filtration Rate) calculated from the MDRD (Modification of Diet in Renewal
Phase) formula < 90 mL/min/1.73m2
5) A case that QTc interval >450 ms is checked
6) A person who is positive for serum test (paroxic test, hepatitis B test, hepatitis C test, HIV test)
7) A person who, after a three-minute break, shows a corresponding figure of less than 90 mmHg or more than 150 mmHg of systolic blood pressure and less than 60 mmHg or more than 100 mmHg of dilatation blood pressure of vital signs measured at the left
5. A person who has a history of drug abuse or tested positive for abuse in urine screening tests
6. A person who has taken any ethical drug or oriental medicine within two weeks prior to the expected first dose date, or who has taken any over the counter drug(OTC drug) or health-functional food or vitamin supplements within one week (but may participate in clinical trials if other conditions are reasonable according to the investigator's judgment), or is expected to take such medication
7. A person who has taken a drug that induces and inhibits the drug's metabolic enzymes, such as barbithalide drugs, within one month prior to the expected first dose date
8. A person who participated in other clinical trials (including biological equivalence tests) within six months of the expected first dose date
9. A person who has donated whole blood within two months or donated apheresis blood within one month prior to the expected first dose date, or has received a blood transfusion within one month prior to the expected first dose date
10. A person who drinks continuously (above 21 units/week, 1 unit = 10 g of pure alcohol) or is unable to abstain from drinking for a period from three days prior to the expected first dose date to the last discharge
11. A person who is currently smoking (but may be selected as a subject if he/she stop smoking before three months) or who is unable to stop smoking for the period from three months prior to the expected date of first dose to the last discharge
12. A person who cannot refrain from consuming foods containing grapefruit during the period from three days prior to the expected first dose date to the last discharge
13. A person who has consistently ingested excessive caffeine (over 5
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Single dose: Cmax, Tmax, AUClast, AUCinf, t1/2, CL/F, Vd/F;MAD: Cmax, Cmax,ss, Tmax, Tmax,ss, AUClast, AUCinf, AUCt, AUCt,ss, Cav,ss, Cmin,ss, t1/2, t1/2,ss, PTF(Peak trough fluctuation), Rac(Accumulation ratio), CLss/F, Vd,ss/F
- Secondary Outcome Measures
Name Time Method Monitoring of adverse events (subjective or objective symptoms);Physical examination, vital signs, electrocardiogram, clinical laboratory test (hematology test, blood chemistry test, blood coagulation test, urinary test)