Clinical Study to Investigate the PK Profiles and Safety of CKD-385 in Healthy Volunteers Under Fasting Conditions

December 17, 2020 updated by: Chong Kun Dang Pharmaceutical

A Randomized, Open-label, Single Dose, Crossover Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers Under Fasting Conditions

Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers under Fasting Conditions

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

A randomized, open-label, single dose, crossover study to investigate the pharmacokinetic profiles and safety of high-dose CKD-385 in healthy volunteers under fasting conditions

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.
24

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 Locations

  • Korea, Republic of
    • Siheung-si
      • Gyeonggi-do, Siheung-si, Korea, Republic of, 15079
        • Central Hospital

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy adult aged more than 19 at the time of screening

  2. Those who had 18.0kg/m² ≤ Body Mass Index (BMI) < 30.0kg/m²

    # BMI=Weight(kg) / Height(m)²

  3. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings on a medical examination.
  4. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, urinalysis, serology), vital signs and ECG results at screening.
  5. Those who have voluntarily given written informed consents to participate in the study and to comply with all the instructions, based on full understanding of the nature of the study after listening to detailed explanations.
  6. Those who agree to double contraception method from the 1st administration of the investigational product until 7 days after the last administration of investigational product.

Exclusion Criteria:

  1. Those who has medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases(except for simple dental history such as tartar, impacted teeth, wisdom teeth).
  2. Those with a medical history of gastrointestinal disorders(esophageal achalasia or esophagus stenosis, Crohn's disease) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery or tooth extraction surgery) that may affect the absorption of drug.
  3. Those who has a history of regular alcohol consumption in excess of 14 glasses/week for woman, 21 glasses/week for man within 1 months prior to screening.
  4. Those who received investigational products or bioequivalence test drugs within 6 months before the first administration of clinical trial drugs.
  5. Those who take drugs which may cause induction or inhibition of drug metabolism within 30 days before the first administration of investigational products.
  6. Those who have taken any drugs that may affect the clinical trial within 10 days.
  7. Those who donated whole blood within 2 months, or blood components within 2 week before first administration of investigational products.
  8. Those who are deemed insufficient to participate in this clinical study by investigators.

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: CROSSOVER
  • Masking: NONE

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: Group 1
  1. Period 1: Reference drug
  2. Period 2: Test drug 1
  3. Period 3: Test drug 2
Drug: Reference drug
1 Cap., single oral administration under fasting condition
Other Names:
  • D744
Drug: Test drug 1
1 Tab., single oral administration under fasting condition
Other Names:
  • CKD-385 64 mg formulation I (878mg)
Drug: Test drug 2
1 Tab., single oral administration under fasting condition
Other Names:
  • CKD-385 64 mg formulation I (878mg)
EXPERIMENTAL: Group 2
  1. Period 1: Test drug 2
  2. Period 2: Reference drug
  3. Period 3: Test drug 1
Drug: Reference drug
1 Cap., single oral administration under fasting condition
Other Names:
  • D744
Drug: Test drug 1
1 Tab., single oral administration under fasting condition
Other Names:
  • CKD-385 64 mg formulation I (878mg)
Drug: Test drug 2
1 Tab., single oral administration under fasting condition
Other Names:
  • CKD-385 64 mg formulation I (878mg)
EXPERIMENTAL: Group 3
  1. Period 1: Test drug 1
  2. Period 2: Test drug 2
  3. Period 3: Reference drug
Drug: Reference drug
1 Cap., single oral administration under fasting condition
Other Names:
  • D744
Drug: Test drug 1
1 Tab., single oral administration under fasting condition
Other Names:
  • CKD-385 64 mg formulation I (878mg)
Drug: Test drug 2
1 Tab., single oral administration under fasting condition
Other Names:
  • CKD-385 64 mg formulation I (878mg)
EXPERIMENTAL: Group 4
  1. Period 1: Test drug 2
  2. Period 2: Test drug 1
  3. Period 3: Reference drug
Drug: Reference drug
1 Cap., single oral administration under fasting condition
Other Names:
  • D744
Drug: Test drug 1
1 Tab., single oral administration under fasting condition
Other Names:
  • CKD-385 64 mg formulation I (878mg)
Drug: Test drug 2
1 Tab., single oral administration under fasting condition
Other Names:
  • CKD-385 64 mg formulation I (878mg)
EXPERIMENTAL: Group 5
  1. Period 1: Test drug 1
  2. Period 2: Reference drug
  3. Period 3: Test drug 2
Drug: Reference drug
1 Cap., single oral administration under fasting condition
Other Names:
  • D744
Drug: Test drug 1
1 Tab., single oral administration under fasting condition
Other Names:
  • CKD-385 64 mg formulation I (878mg)
Drug: Test drug 2
1 Tab., single oral administration under fasting condition
Other Names:
  • CKD-385 64 mg formulation I (878mg)
EXPERIMENTAL: Group 6
  1. Period 1: Reference drug
  2. Period 2: Test drug 2
  3. Period 3: Test drug 1
Drug: Reference drug
1 Cap., single oral administration under fasting condition
Other Names:
  • D744
Drug: Test drug 1
1 Tab., single oral administration under fasting condition
Other Names:
  • CKD-385 64 mg formulation I (878mg)
Drug: Test drug 2
1 Tab., single oral administration under fasting condition
Other Names:
  • CKD-385 64 mg formulation I (878mg)

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
Measure Description
Time Frame
AUCt of CKD-385
Time Frame: Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours
Area under the concentration-time curve from time zero to time of CKD-385
Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours
Cmax of CKD-385
Time Frame: Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours
Maximum plasma concentration of CKD-385
Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 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
Measure Description
Time Frame
AUCinf of CKD-385
Time Frame: Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours
Area under the concentration-time curve from zero up to infinity of CKD-385
Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours
Tmax of CKD-385
Time Frame: Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours
Time to maximum plasma concentration of CKD-385
Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours
T1/2 of CKD-385
Time Frame: Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours
Terminal elimination half-life of CKD-385
Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours
CL/F of CKD-385
Time Frame: Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours
Apparent clearance of CKD-385
Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours
Vd/F of CKD-385
Time Frame: Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours
Apparent Volume of Distribution of CKD-385
Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 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.
Chong Kun Dang Pharmaceutical

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: Min-gi Kim, Central Hospital

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.
October 29, 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.
December 12, 2020

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.
December 12, 2020

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).
November 26, 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.
December 17, 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.
December 21, 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.
December 21, 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.
December 17, 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.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • A88_08BE2015P

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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