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

NCT04297865 | Unknown Phase 1 DMC

• 1 other identifier: CJ_JSI_101
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (22)

• 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 Outcomes (19)

• 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

Study Arms (6)

A dose as CJ-15314 or placebo

EXPERIMENTAL

Oral administration of A as CJ-15314 or placebo once a day

Drug: A dose as CJ-15314; Drug: Placebo

B dose as CJ-15314 or placebo

EXPERIMENTAL

Oral administration of B as CJ-15314 or placebo once a day

Drug: B dose as CJ-15314; Drug: Placebo

C dose as CJ-15314 or placebo

EXPERIMENTAL

Oral administration of C as CJ-15314 or placebo once a day and once daily for 7 days

Drug: C dose as CJ-15314; Drug: Placebo

D dose as CJ-15314 or placebo

EXPERIMENTAL

Oral administration of D as CJ-15314 or placebo once a day and once daily for 7 days

Drug: D dose as CJ-15314; Drug: Placebo

E dose as CJ-15314 or placebo

EXPERIMENTAL

Oral administration of E as CJ-15314 or placebo once a day and once daily for 7 days

Drug: E dose as CJ-15314; Drug: Placebo

F dose as CJ-15314 or placebo

EXPERIMENTAL

Oral administration of F as CJ-15314 or placebo once a day and once daily for 7 days

Drug: F dose as CJ-15314; Drug: Placebo

Interventions

A dose as CJ-15314 DRUG

A dose as CJ-15314, 1 capsule

A dose as CJ-15314 or placebo

B dose as CJ-15314 DRUG

B dose as CJ-15314, 1 capsule

B dose as CJ-15314 or placebo

C dose as CJ-15314 DRUG

C dose as CJ-15314, 1 capsule

C dose as CJ-15314 or placebo

D dose as CJ-15314 DRUG

D dose as CJ-15314, 2 capsules

D dose as CJ-15314 or placebo

E dose as CJ-15314 DRUG

E dose as CJ-15314, 1 capsule

E dose as CJ-15314 or placebo

F dose as CJ-15314 DRUG

F dose as CJ-15314, 2 capsules

F dose as CJ-15314 or placebo

Placebo DRUG

Placebo, 1 capsule

A dose as CJ-15314 or placebo

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Seoul National University Hospital, Dept. of Clinical Pharmacology

Seoul, South Korea

RECRUITING

Study Officials

• In-Jin Jang, MD, PhD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hukeun Lee, MS

CONTACT

+82-2-6477-0208; hukeun.lee@kolmar.co.kr

Seokuee Kim, MD, PhD

CONTACT

+82-2-6477-0207; seokuee.kim@kolmar.co.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: March 6, 2020
• Study Start: February 24, 2020
• Primary Completion: January 1, 2021
• Study Completion: February 1, 2021
• Last Updated: March 6, 2020

Record last verified: 2020-03

Locations

KR (1)