Phase 1 Clinical Trial to Evaluate the Effect of DWP14012 on the Pharmacokinetics of DWC202201 in Healthy Subjects

April 2, 2023 updated by: Daewoong Pharmaceutical Co. LTD.

A Randomized, Open-label, Three-period, Three-sequence, Multiple Dosing Crossover, Phase 1 Clinical Trial to Evaluate the Effect of DWP14012 on the Pharmacokinetics of DWC202201 After Co-administration of DWP14012 and DWC202201 in Healthy Subjects

A randomized, open-label, three-period, three-sequence, multiple dosing crossover, phase 1 clinical trial to evaluate the effect of DWP14012 on the pharmacokinetics of DWC202201 after co-administration of DWP14012 and DWC202201 in healthy subjects

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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 (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.
36

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

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy adults aged ≥ 19 and ≤ 50 years at screening

  • Subjects with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 27.0 kg/m2 at screening

    ※ BMI (kg/m2) = body weight (kg)/[height (m)]2

  • Subjects who voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information
  • Subjects who are eligible to participate in the study at the discretion of the investigator by physical examination, laboratory tests, and investigator questioning, etc.

Exclusion Criteria:

  • Subjects with a disease or a history related to hepatobiliary system, kidney(severe kidney disorder ect.), nervous system, respiratory system, digestive system, endocrine system, hematology system, circulatory system(Heart failure, Torsades de pointes ect.), unrinary system, psychiatry ect.
  • Subjects with digestive disease(gastrointestinal ulcers, gastritis, stomach cramps, gastroesophageal disease, Crohn's disease) or history of surgery(except appendectomy, hernia surgery) which can affect on saftey and pharmacodynamics
  • Subjects with hypersensitivity or history of clinically significant hypersensitivity to drugs including potassium competitive acid blocker [P-CAB] class, aspirin, antibiotics, etc.
  • Subjects with hereditary disorders including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
  • Subjects with history of inherited muscle disorders
  • Subjects with a history of drug abuse or a positive result of using abusive drugs in the urine drug screen
  • Subjects who participated in other clinical trials (including bioequivalence studies) within 6 months prior to the first scheduled dose of the IP
  • Subjects who donated whole blood within 2 months, donated blood components within 1 month, or received blood transfusion within 1 month prior to the first scheduled dose
  • Subjects who are unable to refrain from grapefruit-containing products from 3 days prior to the first scheduled dose until last discharge from hospital
  • Subjects or their spouses or partners who are unable to use medically acceptable appropriate double-method of contraception or medically acceptable contraception throughout the study period and for at least 4 weeks after the last IP administration
  • Subjects who are unable to refrain from smoking(>10pieces/day) from 3 days prior to the first scheduled dose until last discharge from hospital
  • Subjects with alchoholic disorders or subjects who are unable to refrain from drinking(>21units/week) from 3 days prior to the first scheduled dose until last discharge from hospital
  • Subjects who are unable to refrain from caffein(>5units/day) from 3 days prior to the first scheduled dose until last discharge from hospital

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 Assignment
  • Masking: None (Open Label)

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: Cohort 1
  • Treatment A: DWC202201 40 mg qd for 7 days
  • Treatment B: DWP14012 40 mg qd for 7 days, followed by DWC202201 40 mg qd + DWP14012 40 mg qd for 7 days
  • Treatment C: DWP14012 40 mg qd for 14 days
Drug: DWP14012
Potassium-competitive acid blocker
Drug: DWC202201
Atorvastatin Calcium Trihydrate
Experimental: Cohort 2
  • Treatment C: DWP14012 40 mg qd for 14 days
  • Treatment A: DWC202201 40 mg qd for 7 days
  • Treatment B: DWP14012 40 mg qd for 7 days, followed by DWC202201 40 mg qd + DWP14012 40 mg qd for 7 days
Drug: DWP14012
Potassium-competitive acid blocker
Drug: DWC202201
Atorvastatin Calcium Trihydrate
Experimental: Cohort 3
  • Treatment B: DWP14012 40 mg qd for 7 days, followed by DWC202201 40 mg qd + DWP14012 40 mg qd for 7 days
  • Treatment C: DWP14012 40 mg qd for 14 days
  • Treatment A: DWC202201 40 mg qd for 7 days
Drug: DWP14012
Potassium-competitive acid blocker
Drug: DWC202201
Atorvastatin Calcium Trihydrate

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
Atorvastatin Peak Plasma Concentration at steady state (Cmax,ss) after DWC202201 multiple dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Atorvastatin Area under the plasma concentration versus time curve at steady state (AUCinf, ss) after DWC202201 multiple dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]

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
Atorvastatin Area under the plasma concentration extrapolated to infinity at steady state (AUC,ss) after DWC202201 multiple dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Atorvastatin Time to peak drug concentration at staedy state (Tmax, ss) after DWC202201 multiple dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Atorvastatin Terminal Half-life at steady state (T1/2,ss) after DWC202201 multiple dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Atorvastatin Apparent total body clearance at steady state (CLss/F) after DWC202201 multiple dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Atorvastatin Apparent volume of distribution at steady state (Vd,ss/F) after DWC202201 multiple dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Atorvastatin active metabolite Area under the plasma concentration versus time curve at steady state (AUCinf, ss) after DWC202201 multiple dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Atorvastatin active metabolite Terminal Half-life at steady state (T1/2,ss) after DWC202201 multiple dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Atorvastatin active metabolite An estimate of the total body clearance at steady state (CL ss/F) after DWC202201 multiple dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Atorvastatin active metabolite Apparent volume of distribution at steady state (Vd,ss/F) after DWC202201 multiple dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Atorvastatin active metabolite metabolic ratio after DWC202201 multiple dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Fexuprazan Peak Plasma Concentration (Cmax) after DWP14012 single dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Fexuprazan Area under the plasma drug concentration-time curve from 0 to tau (AUCtau) after DWP14012 single dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Fexuprazan Area under the plasma drug concentration-time curve from 0 to infinity(AUCinf) after DWP14012 single dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Fexuprazan The time of peak concentration (Tmax) after DWP14012 single dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Fexuprazan Terminal Half-life (t1/2) after DWP14012 single dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Fexuprazan Apparent Clearance (CL/F) after DWP14012 single dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Fexuprazan Apparent Volume of Distribution After extravascular administration (Vd/F) after DWP14012 single dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Fexuprazan Peak Plasma Concentration at steady state (Cmax,ss) after DWP14012 multiple dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Fexuprazan Area under the plasma drug concentration-time curve from 0 to tau at steady state (AUCtau,ss) after DWP14012 multiple dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Fexuprazan Area under the plasma drug concentration-time curve from 0 to infinity at steady state (AUCinf,ss) after DWP14012 multiple dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Fexuprazan Time of Maximum Concentration at steady state (Tmax,ss) after DWP14012 multiple dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Fexuprazan Terminal Half-life at steady state (t1/2,ss) after DWP14012 multiple dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Fexuprazan An estimate of the total body clearance at steady state (CL ss/F) after DWP14012 multiple dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Fexuprazan Aapparent volume of distribution after extravascular administration at steady state (Vd,ss/F) after DWP14012 multiple dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Fexuprazan Accumulation ratio after DWP14012 multiple dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Fexuprazan active metabolite Peak Plasma Concentration (Cmax) after single dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Fexuprazan active metabolite Area under the plasma drug concentration-time curve from 0 to tau (AUCtau) after single dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Fexuprazan active metabolite Area under the plasma concentration extrapolated to infinity (AUCinf) after single dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Fexuprazan active metabolite The time of peak concentration (Tmax) after single dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Fexuprazan active metabolite metabolic ratio after single dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Fexuprazan active metabolite Peak Plasma Concentration at steady state (Cmax,ss) after multiple dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Fexuprazan active metabolite AUCtau,ss AUCinf,ss Tmax,ss metabolic ratio
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Fexuprazan active metabolite Area under the plasma drug concentration-time curve from 0 to tau at steady state (AUCtau,ss) after multiple dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Fexuprazan active metabolite Area under the plasma concentration extrapolated to infinity at steady state (AUCinf,ss) after multiple dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Fexuprazan active metabolite The time of peak concentration at steady state (Tmax,ss) after multiple dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]
Fexuprazan active metabolite metabolic ratio after multiple dosing
Time Frame: [Time Frame: up to 64 days]
[Time Frame: up to 64 days]

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.
Daewoong Pharmaceutical Co. LTD.

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 26, 2022

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.
March 28, 2023

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.
June 16, 2023

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 14, 2022

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.
April 2, 2023

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.
April 13, 2023

Study Record Updates

Last Update Posted (Estimate)

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.
April 13, 2023

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.
April 2, 2023

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.
April 1, 2023

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.
  • DW_DWP14012109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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