Status:
UNKNOWN
Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CJ-15314 Phosphate in Healthy Male Subjects
Lead Sponsor:
HK inno.N Corporation
Conditions:
Healthy
Eligibility:
MALE
19-55 years
Phase:
PHASE1
Brief Summary
This study aims to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of CJ-15314 phosphate in healthy male subjects.
Detailed Description
* To evaluate the safety, tolerability and pharmacokinetics of single or multiple dose of CJ-15314 phosphate in healthy male subjects * To explore the pharmacodynamics of single or multiple dose of CJ...
Eligibility Criteria
Inclusion
- Healthy male adults aged 19 to 55 years (inclusive) at the time of signing the informed consent form.
- Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m\^2 with a body weight ≥ 50.0 kg and ≤ 90.0 kg at screening.
- ☞ BMI (kg/m\^2) = weight (kg) / {height (m)}\^2
- Decides to participate voluntarily in the study after being fully informed of and understanding the study completely, and provides his written informed consent prior to screening procedure.
- Determined eligible for this study in the opinion of the investigator based on the results of vital signs, physical examination, 12-lead electrocardiogram, clinical laboratory tests, and medical interview drug screening test.
Exclusion
- Has a history or current evidence of clinically significant disorder of hepatic, renal, nervous, respiratory, endocrine, hemato-oncologic, cardiovascular, urinary, and/or psychiatric system.
- Has a history or current evidence of gastrointestinal disease that may affect the safety and PD assessment of IP or a history of gastrointestinal surgery (except for simple appendectomy or herniotomy).
- Has rheumatoid arthritis or has a history.
- Has symptomatic herpes simplex or herpes zoster or has a history within 3 months prior to the scheduled first dose.
- Has live vaccine dose within 3 months prior to the scheduled first dose or expects to receive live vaccine during the clinical trial period.
- Has a history or current evidence of clinically significant hypersensitivity to drugs containing any ingredient of Janus kinase inhibitor and other drugs.
- Has a positive result on serology tests (for hepatitis B, hepatitis C and human immunodeficiency virus \[HIV\]) during screening test.
- Has abnormalities one or more of the following during screening test: AST \[GOT\] or ALT \[GPT\] \> 1.5 X upper limit of normal (ULN), Creatinine \> upper limit of normal (ULN), ANC \< 2,000/uL, Hb \<12.5 g/dL, Platelet \< 150,000/uL, QTc interval at 12-lead electrocardiogram \> 450 msec
- Systolic blood pressure (SBP) \< 90 mmHg or \> 140 mmHg, diastolic blood pressure (DBP) \< 50 mmHg or \> 95 mm Hg, or pulse rate (PR) \< 45 beats/min or \> 100 beats/min on vital signs measured in sitting position after taking a rest for at least 5 minutes during screening test.
- Has a history of drug abuse or has a positive response to drug abuse on urine drug screening test.
- Has taken any prescription drugs or herbal medicine within 2 weeks prior to the expected date of first dose, or has taken or is expected to take any over-the-counter (OTC) drug, health functional food or vitamin preparation within 1 week prior to the expected date of the first dose (However, can participate in the study if otherwise eligible in the judgment of the investigator).
- Has participated in any other clinical study or bioequivalence study and received IPs within 6 months prior to the scheduled first dose.
- Has donated whole blood within 2 months prior to the scheduled first dose, or has donated blood components or received transfusion within a month prior to the scheduled first dose.
- Has a history of excessive smoking (\> 10 cigarettes/day) within 3 months prior to the scheduled first dose or confirmed as positive for cotinine on urine drug screening test.
- Excessive caffeine intake (\> 5 units/day), continued use of alcohol (\> 21 units/week, 1 unit = 10 g of pure alcohol), or unable to stop drinking during hospitalization period.
- Unable to avoid caffeine-containing foods (e.g., coffee, tea \[black tea, green tea, etc.\], soda, coffee-flavored milk, and nutritive tonic drink) during the period from 24 hrs before hospitalization to discharge.
- Unable to use a medically acceptable contraceptive method throughout the study.
- ► Medically acceptable contraceptive methods include:
- Use of intrauterine device with a proven birth control failure rate by the spouse (or partner)
- Simultaneous use of (male or female) barrier method and spermicide
- Surgical sterilization of the subject or his partner (e.g., vasectomy, salpingectomy, tubal ligation, or hysterectomy)
- Determined ineligible for study participation by the investigator for other reasons such as clinical laboratory abnormalities.
Key Trial Info
Start Date :
February 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2021
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04297865
Start Date
February 24 2020
End Date
February 1 2021
Last Update
March 6 2020
Active Locations (1)
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1
Seoul National University Hospital, Dept. of Clinical Pharmacology
Seoul, South Korea