The Exploration for Pharmacodynamics and Pharmacokinetics of YH4808 New Formulation in Healthy Subjects

December 26, 2021 updated by: Yuhan Corporation

A Randomized, Open-label, Multiple-dose, Partial Crossover Study to Explore the Pharmacokinetics and the Pharmacodynamics of YH4808 New Formulation in Healthy Subjects

The objective of this clinical trial is to explore pharmacodynamics and pharmacokinetics of YH4808 New Formulation in healthy volunteers.

Study Overview

Status

Status

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

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.

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 (Actual)

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.
82

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
      • Seoul, Korea, Republic of
        • Yonsei Medical Center Severance Hospital Clinical Trials Center

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

All

Description

Inclusion Criteria:

  1. healthy adult age 20 to 55 over 55kg with ideal body weight(BMI) 18.5 ~ 25
  2. Subject who has no congenital, chronic disease and disease symptoms in medical examination result
  3. negative to Helicobacter pylori in 13C urea breath test
  4. Subject who judged to be eligible according to various test results including laboratory test(serum test, hematologic/blood chemistry examination, urine test, etc.) and 12-lead ECG test performed within 4 weeks before the first IP administration.
  5. Subject who agreed to maintain contraception and comply with medically verified contraception methods (including infertility)

Exclusion Criteria:

  1. Subject who has history or presence of clinically significant disease in liver, kidney, nervous system, respiratory system, endocrine system, blood tumor, cardiovascular, reproductive, musculoskeletal system, mental disorder, ophthalmologic disease, and skin disease in investigator's judgement.
  2. Subject who has history of surgical operation or disease related to gastrointestinal symptoms (e.g. crohn's diseas, ulcer, etc. except for appendectomy or simple hernia) which could have influence on the absorption of IP.
  3. Subject who is hypersensitive to components contained in YH4808 and other drugs(aspirin, antibiotics, etc.)
  4. pregnant or lactating woman.
  5. Other exclusions apply.

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: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • 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: Cohort1-YH4808 NF 100
7 days repeat administration of YH4808 New Formulation 100mg after meal
Drug: YH4808 NF 100
The number of times : multiple-dose Rout : oral administration
EXPERIMENTAL: Cohort1-YH4808 OF 200
(Partial cross over design) 7 days repeat administration of YH4808 Old Formulation 200mg after meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 New Formulation 200mg after meal
Drug: YH4808 OF 200
The number of times : multiple-dose Rout : oral administration
Drug: YH4808 NF 200
The number of times : multiple-dose Rout : oral administration
EXPERIMENTAL: Cohort1-YH4808 NF 200
(Partial cross over design) 7 days repeat administration of YH4808 New Formulation 200mg after meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg after meal
Drug: YH4808 OF 200
The number of times : multiple-dose Rout : oral administration
Drug: YH4808 NF 200
The number of times : multiple-dose Rout : oral administration
EXPERIMENTAL: Cohort1-YH4808 NF 400
7 days repeat administration of YH4808 New Formulation 400mg after meal
Drug: YH4808 NF 400
The number of times : multiple-dose Rout : oral administration
EXPERIMENTAL: Cohort2-YH4808 NF 100
7 days repeat administration of YH4808 New Formulation 100mg before meal
Drug: YH4808 NF 100
The number of times : multiple-dose Rout : oral administration
EXPERIMENTAL: Cohort2-YH4808 NF 200
(Partial cross over design) 7 days repeat administration of YH4808 New Formulation 200mg before meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before meal
Drug: YH4808 OF 200
The number of times : multiple-dose Rout : oral administration
Drug: YH4808 NF 200
The number of times : multiple-dose Rout : oral administration
EXPERIMENTAL: Cohort2-YH4808 OF 200
(Partial cross over design) 7 days repeat administration of YH4808 New Formulation 200mg before meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before meal
Drug: YH4808 OF 200
The number of times : multiple-dose Rout : oral administration
Drug: YH4808 NF 200
The number of times : multiple-dose Rout : oral administration
EXPERIMENTAL: Cohort2-YH4808 NF 400
7 days repeat administration of YH4808 New Formulation 400mg before meal
Drug: YH4808 NF 400
The number of times : multiple-dose Rout : oral administration
EXPERIMENTAL: Cohort3-YH4808 OF 200

(Partial cross over design)

  1. 7 days repeat administration of YH4808 Old Formulation 200mg before bed, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before dinner
  2. 7 days repeat administration of YH4808 Old Formulation 200mg before dinner, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before bed
Drug: YH4808 OF 200
The number of times : multiple-dose Rout : oral administration
EXPERIMENTAL: Cohort3-YH4808 OF 400

(Partial cross over design)

  1. 7 days repeat administration of YH4808 Old Formulation 400mg before bed, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 400mg before dinner
  2. 7 days repeat administration of YH4808 Old Formulation 400mg before dinner, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 400mg before bed
Drug: YH4808 OF 200
The number of times : multiple-dose Rout : oral administration

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
The Cmax of YH4808
Time Frame: Day 1(Day 35), Day 7(Day 41)
Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing
Day 1(Day 35), Day 7(Day 41)
The AUC0-24h of YH4808
Time Frame: Day 1(Day 35), Day 7(Day 41)
Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing
Day 1(Day 35), Day 7(Day 41)
The AUC0-24h of M3
Time Frame: Day 1(Day 35), Day 7(Day 41)
Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing
Day 1(Day 35), Day 7(Day 41)
The Cmax of M3
Time Frame: Day 1(Day 35), Day 7(Day 41)
Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing
Day 1(Day 35), Day 7(Day 41)

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
the arithmetic mean of 24h intragastric pH monitoring
Time Frame: Day 1(Day7)~Day2(Day8)
Day 1(Day7)~Day2(Day8)
the median of 24h intragastric pH monitoring
Time Frame: Day 1(Day7)~Day2(Day8)
Day 1(Day7)~Day2(Day8)
The Duration of stomach maintained over pH4 or 5
Time Frame: Day 1(Day7)~Day2(Day8)
Day 1(Day7)~Day2(Day8)

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.
Yuhan 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: Min soo Park, Ph.D, M.D., Yonsei Medical Center Severance Hospital Clinical Trials Center

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

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.
June 1, 2014

Primary Completion (ACTUAL)

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.
November 1, 2014

Study Completion (ACTUAL)

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.
November 1, 2014

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).
June 11, 2014

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.
June 26, 2014

First Posted (ESTIMATE)

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.
June 27, 2014

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.
January 13, 2022

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 26, 2021

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.
February 1, 2015

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.
  • YH4808-111

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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