A First-in-Human, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics of WK0202 Capsule in Healthy Adult Male and Female Subjects
- Conditions
- Not Applicable
- Registration Number
- KCT0004830
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
1) Healthy adult aged 19 ~ 45 on the day of screening
2) Weight = 50.0kg, 18.0 = BMI = 27.0
? Body Mass Index (BMI, kg/m2) = Weight (kg)/[height(m)2]
3) During the study period, female subjects must agree to use following contraception or female partners of male subjects must be as follows,
? Female subjects or female partners of male subjects is in menopause (more than 12 months of non-therapy induced amenorrhoea)
? Female subjects or female partners of male subjects is surgically infertile (Ovary and/or uterus removed)
? Subject who agreed to absolute abstinence during the study period [for female subjects, intermittent abstinence (e.g., ovulation period, symptothermal method, ovulation secretory phase) or external ejaculation does not meet absolute abstinence]
? If female subjects or female partners of male subjects are women of childbearing potential(WOCBP) that did not receive sterilization operation, they must agree to the following method of contraception
a. Both female subjects and female partners of male subjects apply: intrauterine contraception / ovarian conjunctomy and sterilization operation / combination use of condoms or diaphragm and spermicide
b. Male subjects (does not apply for male partners of female subjects): Combination use of condom and spermicide
[Reference: Oral hormonal contraceptives or hormonal contraceptives of intradermal insertion does not meet the standards of contraception in this study. Only sexual partners of male subjects are allowed to use the oral hormonal contraception]
4) Upon receiving sufficient explanation and complete understanding of this study, the subject who has agreed in writing to participate and to comply with the precautions
5) A person who is qualified as a test subject by the investigator's decision based on physical examination, laboratory examination, medication examination, etc.
1) Subject with a history or evidence of clinically significant hepatic (severe liver dysfunction, etc.), renal (severe kidney dysfunction, etc.), neuronal, immunologic, respiratory, endocrinal, hematologic (except in cases where no such disease has occurred for more than 10 years or where malignant tumors are only basal or squamous cell carcinoma of the skin), cardiovascular (cardiac failure, Torsades de pointes, etc.), psychiatric disease or disorder
2) Subject with a history of gastrointestinal disease (Crohn's disease, ulcer, etc.) or surgery (exception: simple appendectomy and hernia surgery) which could affect the safety, pharmacokinetic/pharmacodynamic evaluation of the test drug
3) Subject with a history of clinically significant hypersensitive reactions to WK0202, drugs that consists of/related to WK0202, or other drugs(aspirin, antibiotics, etc.)
4) Subject who was deemed unfit for the study in a screen test conducted within 28 days prior to the administration
(1) If the blood AST, ALT level is above the upper limit of the normal range by > 1.5 times
(2) If the total bilirubin level is above the upper limit of the normal range by > 1.5 times
(3) If the blood CPK level is above the upper limit of the normal range by > 1.5 times
(4) If the estimated glomerular filtration rate (eGFR) determined by modification of diet in renal disease (MDRD) is < 90 mL/min/1.73m2
(5) If the subject tested positive in a serum test (type B hepatitis, type C hepatitis, human immunodeficiency virus (HIV) test)
(6) If the subject has vital signs of systolic blood pressure of > 150 mmHg or < 90 mmHg, or diastolic blood pressure of > 100 mmHg or < 50 mmHg
(7) QTc interval > 450 ms
5) Subject has a history of drug abuse or tested positive for the abusable drug in urine screening test
6) If the subject has taken prescription drugs or oriental medicine within 14 days prior to the first day of test drug administration or taken over-the-counter drug or vitamin within 7 days prior to the first day of test drug administration, the subject may be disqualified if the investigator judges the drug or vitamin to be capable of affecting the test or affecting the safety of the subject
7) Subject has taken drugs such as barbital drugs or drugs that induce/inhibit drug metabolizing enzyme
8) Current smoker (exception: if the subject has quit smoking more than 90 days prior to the first day of test drug administration)
9) If the subject continuously consume alcohol (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) within 3 days prior to the first day of test drug administration or if the subject is unable to remain sober from 3 days prior to the first day of test drug administration until the post-study visit (PSV)
10) Subject is unable to stop consuming beverages containing caffeine (coffee, tea (black tea, green tea, etc.)) from 3 days prior to the first day of test drug administration until the post-study visit (PSV)
11) Subject is unable to stop consuming beverages or foods containing grapefruit from 3 days prior to the first day of test drug administration until the post-study visit (PSV)
12) Subject participated in another clinical trial of which the last test drug administration day is less than 6 months prior to the first day of test drug administration for current trial
13) Subject has donated whole blood within 60 days prior to the first day of test drug administration or has donated apheresis 30 days prior to the first
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood (1) Part1&3 Single dose: AUClast, AUCinf, Cmax, Tmax, t1/2, CL/F, Vz/F, CLR, fe; (2) Part2 Repeat dose: AUCt, Cmax,ss, Cmin,ss, Cav,ss, Tmax,ss, t1/2, PTF, fe, CLss /F, CLR, Vdss/F;Urine (1) Part1&3 Single dose: AUClast, AUCinf, Cmax, Tmax, t1/2, CL/F, Vz/F, CLR, fe; (2) Part2 Repeat dose: AUCt, Cmax,ss, Cmin,ss, Cav,ss, Tmax,ss, t1/2, PTF, fe, CLss /F, CLR, Vdss/F
- Secondary Outcome Measures
Name Time Method Adverse events (subjective or objective symptoms);Vital Signs, Physical Examination, 12-lead ECG, Clinical Lab Test