Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CJ-15314 Phosphate in Healthy Male Subjects
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This study aims to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of CJ-15314 phosphate in healthy male subjects.
Full 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-15314 phosphate in healthy male subjects
- To explore the pharmacokinetics of CJ-15314 Phosphate active metabolites of single or multiple dose of CJ-15314 phosphate in healthy male subjects
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
-
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 criteria
-
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
55 participants in 6 patient groups
Trial contacts and locations
Loading...
Central trial contact
Seokuee Kim, MD, PhD; Hukeun Lee, MS
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal