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

March 3, 2020 updated by: HK inno.N Corporation

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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-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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital, Dept. of Clinical Pharmacology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Drug: Placebo
Placebo, 2 capsules
EXPERIMENTAL: B dose as CJ-15314 or placebo
Oral administration of B as CJ-15314 or placebo once a day
Drug: Placebo
Placebo, 1 capsule
Drug: Placebo
Placebo, 2 capsules
Drug: B dose as CJ-15314
B dose as CJ-15314, 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: Placebo
Placebo, 1 capsule
Drug: Placebo
Placebo, 2 capsules
Drug: C dose as CJ-15314
C dose as CJ-15314, 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: Placebo
Placebo, 1 capsule
Drug: Placebo
Placebo, 2 capsules
Drug: D dose as CJ-15314
D dose as CJ-15314, 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: Placebo
Placebo, 1 capsule
Drug: Placebo
Placebo, 2 capsules
Drug: E dose as CJ-15314
E dose as CJ-15314, 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: Placebo
Placebo, 1 capsule
Drug: Placebo
Placebo, 2 capsules
Drug: F dose as CJ-15314
F dose as CJ-15314, 2 capsules

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Cmax of single dose of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
Tmax of single dose of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
AUClast of single dose of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
AUCinf of single dose of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
t1/2 of single dose of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
λz of single dose of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
CL/F of single dose of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
Vd/F of single dose of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
Ae of single dose of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
fe of single dose of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
CLR of single dose of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
Cmax,ss of multiple doses of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
Cmin,ss of multiple doses of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
Cav,ss of multiple doses of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
Tmax,ss of multiple doses of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
AUCtau,ss of multiple doses of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
t1/2 of multiple doses of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
PTF of multiple doses of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
Ra of multiple doses of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
Ae of multiple doses of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
fe of multiple doses of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
CLR of multiple doses of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Cmax of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
Tmax of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
AUClast of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
AUCinf of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
t1/2 of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
λz of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
Ae of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
fe of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
Metabolic ratio of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
Cmax,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
Cmin,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
Cav,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
Tmax,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
AUCtau,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
t1/2 of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
PTF of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
Ra of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
Ae of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours
Metabolic ratio of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Time Frame: Up to 72 hours
Up to 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HK inno.N Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: In-Jin Jang, MD, PhD, study principal investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CJ_JSI_101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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