Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics of KDS2010 after oral administration in healthy young and elderly subjects
- Conditions
- Not Applicable
- Registration Number
- KCT0008331
- Lead Sponsor
- euroBiogen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 88
Young subjects: Healthy Korean or Caucasian volunteers between 19 and 45 years of age at the screening visit
Elderly subjects: Healthy Korean volunteers over 65 years and under 85 years of age at the screening visit
? Caucasian who were born in Europe, have lived outside Europe for less than 10 years, and both parents and grandparents were of European origin
2) Women: Except for surgical infertility (bilateral fallopian tube occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy, etc.), those who tested negative in the urine pregnancy test (hCG) performed at screening
3) Subjects with body weight between 55.0 kg and 90.0 kg and Body Mass Index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the screening visit
? Body Mass Index = body weight(kg)/ [height(m)]2
4) Subjects who completely understand the nature of study and make a voluntary decision to participate in this clinical study and provide the informed consent.
5) Subjects who are considered to be suitable to participate in this study based on physical examination, clinical laboratory test results and medical history
1) Subjects with a clinical evidence or history of hepatic, renal, neurologic, immunologic, respiratory, endocrine, hematologic, oncologic, cardiovascular, psychiatric disease (However, in the case of an elderly person with a history of mild disease, participation is possible if the researcher determines that the drug can be discontinued at least 2 weeks before the expected first dose or 5 times or more before the half-life.)
2) Subjects with a history of gastrointestinal disease (e.g., gastrointestinal ulcers, gastritis, stomach cramp, gastroesophageal reflux disease, Crohn’s disease, etc.) or surgery (except for simple appendectomy or herniotomy), which can influence the safety and pharmacokinetic evaluation of investigational drugs
3) For all women of childbearing age, except for surgical infertility, those who are pregnant, may be pregnant, or are lactating
4) Subjects with clinically significant abnormalities in the neurological examination performed at the screening visit
5) Subjects with any of the following vital signs at the screening visit
? Systolic blood pressure (SBP): < 90 mmHg or > 140 mmHg
? Diastolic blood pressure (DBP): < 50 mmHg or > 90 mmHg
? Heart rate: < 50 bpm or > 90 bpm
6) Subjects with any of the following clinical laboratory test results at the screening visit
? AST, ALT: > upper normal limit × 1.5
? Total bilirubin: > upper normal limit × 1.5
? CPK: > upper normal limit × 1.5
? Creatinine clearance calculated by CKD-EPI equation: < 60 mL/min/1.73m2
? Subjects with a positive result in the serology test (syphilis test, Hepatitis B surface antigen, Hepatitis C antibody, Human immunodeficiency virus(HIV) antibody)
7) Subjects with any of the following ECG results at the screening visit
? PR > 210 msec
? QRS complex > 120 msec
? QTcB > 450 msec
? Other, clinically significant arrhythmias
8) Subjects with a history of hypersensitivities including drug allergies (caused by aspirin, antibiotics, etc.), or a history of clinically significant hypersensitivities
9) Subjects with a history of alcohol or drug abuse, or with positive reaction to any drug of concern for abuse/misuse at the urine drug screening test
10) Subjects who had taken or are expected to take any prescription drug or herbal medicine within 2 weeks or any over the counter (OTC) drug within 1 week prior to the first administration day (however, subjects fulfilling other conditions could participate in the study at the investigator’s discretion)
11) Subjects who had taken an inducer or inhibitor of drug metabolism such as barbiturates etc. within 1 month prior to the first administration day
12) Subjects who had participated in another clinical study (including bioequivalence studies) within 6 months prior to the first administration day
13) Subjects who had donated whole blood or component blood, or received transfusion within 3 months prior to the first administration day
14) Subjects who drink continuously (more than 21 units/week, 1 unit = 10 g of pure alcohol) or are unable to stop drinking during the period from 3 days prior to the first administration day to the end of the study
15) Smokers (except for whom quitted smoking prior to the first administration day for at least 3months) or who cannot stop smoking during the period from 3 months prior to the first administration day to the end of the study
16) Subjects who cannot stop taking grapefruit or food containing grapefruit during the period from 3 days prior to the
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety & tolerability;pharmacokinetics
- Secondary Outcome Measures
Name Time Method pharmacodynamics