Evaluation of biomarkers for JAK inhibitor
- Conditions
- Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism
- Registration Number
- KCT0005706
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 8
1) Healthy male subjects aged 19-55 years
2) Subjects with weight between 50.0 kg and 90.0 kg and BMI between 18.0 kg/m2 and 30.0 kg/m2
3) Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to performing any of the Screening visit procedures
4) Subject who judged eligible for the study from vital signs, physical examinations, 12-lead electrocardiograms, clinical laboratory tests and medical interviews
1) Subject with a history or presence of clinically significant active disease of the hepatic, renal, neurological, pulmonary, endocrine, hematological, oncological, genitourinary or psychiatric system. Especially subject with clinically significant infections(e.g. sepsis), active tuberculosis or untreated latent tuberculosis
2) Subject with history or presence of diseases or any major surgery that can affect pharmacokinetic or pharmacodynamics evaluation (except for appendectomy or repair of hernia)
3) Subject with or with history of rheumatoid arthritis
4) Subject with or with history of symptomatic herpes simplex or varicella-zoster within three months before first expected administration
5) Subject with or expected to have inoculation for live vaccine within three months before first expected administration
6) Subject with hypersensitivity to JAK inhibitor or other medication or clinically significant history of hypersensitivity
7) Subject positive for serology tests (HBV, HCV, HIV) at screening
8) Subject positive for IGRA at screening
6) Subject with any of following results:
- AST or ALT exceeding 1.5 x ULN
- Creatinine exceeding ULN
- ANC less than 2000/uL
- ALC less than 500/uL
- Hb less than 12.5 g/dL
- Platelet less than 150000/uL
- QTc interval > 450 msec at 12-lead ECG
10) Subject with systolic blood pressure > 140 mmHg or < 90 mg; diastolic blood pressure > 95 mmHg or < 50 mmHg
11) Subject with history of drug abuse or positive result in urine drug screening
12) Within 14 days prior to study medication, use of prescription drug or herbal medication or within 7 days use of any over-the-counter medications (if washout periods are more than 5 half-lives of the drug, can be eligible considering absorption, distribution, metabolism and excretion by the investigator’s judgment)
13) Subject who was administerd of another investigational drug (including investigational drug of bioequivalence trial) within 6 months prior to planned administration of the study medication
14) Subject who donated whole blood within 2 months prior to the first administration or blood component donation within 1 month prior to the first administration
15) Subject who smoke excessively (cigarettes > 10 per day) or who cannot quit smoking from 24 hour prior to admission to discharge
16) Subject who cannot quit drinking caffeine containing beverages (coffee, black tea, green tea, cokes, coffee milk or energy drink) during the hospitalization
17) Subject who consumed grapefruit containing food from 24 hour prior to admission to discharge or who cannot quit consuming during the period
18) Subject who do not use medically acceptable contraceptive method during whole study period
? Medically acceptable contraceptive method
- intrauterine contraception/device
- barrier methods (female condom, diaphragm, sponge, cervical cap) together with spermicidal foam/gel/film/cream/suppository
- surgical sterilization (e.g., bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy)
19) Subject who investigator judged ineligible for other reasons
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability
- Secondary Outcome Measures
Name Time Method IL-6 induced pSTAT1 (JAK1);GM-CSF-induced pSTAT5 (JAK2);Absolute reticulocyte count (ARC);Absolute neutrophil count (ANC)