Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CJ-15314 Phosphate in Healthy Male Subjects
Study Details
Study Description
Brief Summary
This study aims to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of CJ-15314 phosphate in healthy male subjects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
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To evaluate the safety, tolerability and pharmacokinetics of single or multiple dose of CJ-15314 phosphate in healthy male subjects
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To explore the pharmacodynamics of single or multiple dose of CJ-15314 phosphate in healthy male subjects
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To explore the pharmacokinetics of CJ-15314 Phosphate active metabolites of single or multiple dose of CJ-15314 phosphate in healthy male subjects
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: A dose as CJ-15314 or placebo Oral administration of A as CJ-15314 or placebo once a day |
Drug: A dose as CJ-15314
A dose as CJ-15314, 1 capsule
Drug: Placebo
Placebo, 1 capsule
|
| Experimental: B dose as CJ-15314 or placebo Oral administration of B as CJ-15314 or placebo once a day |
Drug: B dose as CJ-15314
B dose as CJ-15314, 1 capsule
Drug: Placebo
Placebo, 1 capsule
|
| Experimental: C dose as CJ-15314 or placebo Oral administration of C as CJ-15314 or placebo once a day and once daily for 7 days |
Drug: C dose as CJ-15314
C dose as CJ-15314, 1 capsule
Drug: Placebo
Placebo, 1 capsule
|
| Experimental: D dose as CJ-15314 or placebo Oral administration of D as CJ-15314 or placebo once a day and once daily for 7 days |
Drug: D dose as CJ-15314
D dose as CJ-15314, 2 capsules
Drug: Placebo
Placebo, 2 capsules
|
| Experimental: E dose as CJ-15314 or placebo Oral administration of E as CJ-15314 or placebo once a day and once daily for 7 days |
Drug: E dose as CJ-15314
E dose as CJ-15314, 1 capsule
Drug: Placebo
Placebo, 1 capsule
|
| Experimental: F dose as CJ-15314 or placebo Oral administration of F as CJ-15314 or placebo once a day and once daily for 7 days |
Drug: F dose as CJ-15314
F dose as CJ-15314, 2 capsules
Drug: Placebo
Placebo, 2 capsules
|
Outcome Measures
Primary Outcome Measures
- Cmax of single dose of CJ-15314 [Up to 72 hours]
- Tmax of single dose of CJ-15314 [Up to 72 hours]
- AUClast of single dose of CJ-15314 [Up to 72 hours]
- AUCinf of single dose of CJ-15314 [Up to 72 hours]
- t1/2 of single dose of CJ-15314 [Up to 72 hours]
- λz of single dose of CJ-15314 [Up to 72 hours]
- CL/F of single dose of CJ-15314 [Up to 72 hours]
- Vd/F of single dose of CJ-15314 [Up to 72 hours]
- Ae of single dose of CJ-15314 [Up to 72 hours]
- fe of single dose of CJ-15314 [Up to 72 hours]
- CLR of single dose of CJ-15314 [Up to 72 hours]
- Cmax,ss of multiple doses of CJ-15314 [Up to 72 hours]
- Cmin,ss of multiple doses of CJ-15314 [Up to 72 hours]
- Cav,ss of multiple doses of CJ-15314 [Up to 72 hours]
- Tmax,ss of multiple doses of CJ-15314 [Up to 72 hours]
- AUCtau,ss of multiple doses of CJ-15314 [Up to 72 hours]
- t1/2 of multiple doses of CJ-15314 [Up to 72 hours]
- PTF of multiple doses of CJ-15314 [Up to 72 hours]
- Ra of multiple doses of CJ-15314 [Up to 72 hours]
- Ae of multiple doses of CJ-15314 [Up to 72 hours]
- fe of multiple doses of CJ-15314 [Up to 72 hours]
- CLR of multiple doses of CJ-15314 [Up to 72 hours]
Secondary Outcome Measures
- Cmax of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314 [Up to 72 hours]
- Tmax of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314 [Up to 72 hours]
- AUClast of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314 [Up to 72 hours]
- AUCinf of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314 [Up to 72 hours]
- t1/2 of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314 [Up to 72 hours]
- λz of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314 [Up to 72 hours]
- Ae of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314 [Up to 72 hours]
- fe of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314 [Up to 72 hours]
- Metabolic ratio of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314 [Up to 72 hours]
- Cmax,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314 [Up to 72 hours]
- Cmin,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314 [Up to 72 hours]
- Cav,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314 [Up to 72 hours]
- Tmax,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314 [Up to 72 hours]
- AUCtau,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314 [Up to 72 hours]
- t1/2 of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314 [Up to 72 hours]
- PTF of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314 [Up to 72 hours]
- Ra of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314 [Up to 72 hours]
- Ae of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314 [Up to 72 hours]
- Metabolic ratio of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314 [Up to 72 hours]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy male adults aged 19 to 55 years (inclusive) at the time of signing the informed consent form.
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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
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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.
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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:
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Has a history or current evidence of clinically significant disorder of hepatic, renal, nervous, respiratory, endocrine, hemato-oncologic, cardiovascular, urinary, and/or psychiatric system.
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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).
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Has rheumatoid arthritis or has a history.
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Has symptomatic herpes simplex or herpes zoster or has a history within 3 months prior to the scheduled first dose.
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Has live vaccine dose within 3 months prior to the scheduled first dose or expects to receive live vaccine during the clinical trial period.
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Has a history or current evidence of clinically significant hypersensitivity to drugs containing any ingredient of Janus kinase inhibitor and other drugs.
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Has a positive result on serology tests (for hepatitis B, hepatitis C and human immunodeficiency virus [HIV]) during screening test.
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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
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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.
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Has a history of drug abuse or has a positive response to drug abuse on urine drug screening test.
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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).
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Has participated in any other clinical study or bioequivalence study and received IPs within 6 months prior to the scheduled first dose.
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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.
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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.
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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.
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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.
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Unable to use a medically acceptable contraceptive method throughout the study.
► Medically acceptable contraceptive methods include:
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Use of intrauterine device with a proven birth control failure rate by the spouse (or partner)
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Simultaneous use of (male or female) barrier method and spermicide
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Hospital, Dept. of Clinical Pharmacology | Seoul | Korea, Republic of |
Sponsors and Collaborators
- HK inno.N Corporation
Investigators
- Principal Investigator: In-Jin Jang, MD, PhD, Study Principal Investigator
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CJ_JSI_101