Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CJ-15314 Phosphate in Healthy Male Subjects

Healthy Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CJ-15314 Phosphate in Healthy Male Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04297865
• Other study ID #: CJ_JSI_101
• Status: Recruiting
• Phase: Phase 1
• Start date: February 24, 2020
• Est. completion date: February 2021

Study information

• Verified date: March 2020
• Source: CJ HealthCare Corporation
• Contact: Hukeun Lee, MS
• Phone: +82-2-6477-0208
• Email: hukeun.lee[@]kolmar.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of CJ-15314 phosphate in healthy male subjects.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: February 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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:

1. Use of intrauterine device with a proven birth control failure rate by the spouse (or partner)

2. Simultaneous use of (male or female) barrier method and spermicide

3. 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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• A dose as CJ-15314
A dose as CJ-15314, 1 capsule
• B dose as CJ-15314
B dose as CJ-15314, 1 capsule
• C dose as CJ-15314
C dose as CJ-15314, 1 capsule
• D dose as CJ-15314
D dose as CJ-15314, 2 capsules
• E dose as CJ-15314
E dose as CJ-15314, 1 capsule
• F dose as CJ-15314
F dose as CJ-15314, 2 capsules
• Placebo
Placebo, 1 capsule
• Placebo
Placebo, 1 capsule
• Placebo
Placebo, 1 capsule
• Placebo
Placebo, 2 capsules
• Placebo
Placebo, 1 capsule
• Placebo
Placebo, 2 capsules

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital, Dept. of Clinical Pharmacology	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
CJ HealthCare Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of single dose of CJ-15314		Up to 72 hours
Primary	Tmax of single dose of CJ-15314		Up to 72 hours
Primary	AUClast of single dose of CJ-15314		Up to 72 hours
Primary	AUCinf of single dose of CJ-15314		Up to 72 hours
Primary	t1/2 of single dose of CJ-15314		Up to 72 hours
Primary	?z of single dose of CJ-15314		Up to 72 hours
Primary	CL/F of single dose of CJ-15314		Up to 72 hours
Primary	Vd/F of single dose of CJ-15314		Up to 72 hours
Primary	Ae of single dose of CJ-15314		Up to 72 hours
Primary	fe of single dose of CJ-15314		Up to 72 hours
Primary	CLR of single dose of CJ-15314		Up to 72 hours
Primary	Cmax,ss of multiple doses of CJ-15314		Up to 72 hours
Primary	Cmin,ss of multiple doses of CJ-15314		Up to 72 hours
Primary	Cav,ss of multiple doses of CJ-15314		Up to 72 hours
Primary	Tmax,ss of multiple doses of CJ-15314		Up to 72 hours
Primary	AUCtau,ss of multiple doses of CJ-15314		Up to 72 hours
Primary	t1/2 of multiple doses of CJ-15314		Up to 72 hours
Primary	PTF of multiple doses of CJ-15314		Up to 72 hours
Primary	Ra of multiple doses of CJ-15314		Up to 72 hours
Primary	Ae of multiple doses of CJ-15314		Up to 72 hours
Primary	fe of multiple doses of CJ-15314		Up to 72 hours
Primary	CLR of multiple doses of CJ-15314		Up to 72 hours
Secondary	Cmax of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314		Up to 72 hours
Secondary	Tmax of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314		Up to 72 hours
Secondary	AUClast of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314		Up to 72 hours
Secondary	AUCinf of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314		Up to 72 hours
Secondary	t1/2 of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314		Up to 72 hours
Secondary	?z of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314		Up to 72 hours
Secondary	Ae of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314		Up to 72 hours
Secondary	fe of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314		Up to 72 hours
Secondary	Metabolic ratio of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314		Up to 72 hours
Secondary	Cmax,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314		Up to 72 hours
Secondary	Cmin,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314		Up to 72 hours
Secondary	Cav,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314		Up to 72 hours
Secondary	Tmax,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314		Up to 72 hours
Secondary	AUCtau,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314		Up to 72 hours
Secondary	t1/2 of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314		Up to 72 hours
Secondary	PTF of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314		Up to 72 hours
Secondary	Ra of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314		Up to 72 hours
Secondary	Ae of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314		Up to 72 hours
Secondary	Metabolic ratio of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314		Up to 72 hours