Phase 1 Clinical Trial to Evaluate the Effect of DWP14012 on the Pharmacokinetics of 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

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: Active, not recruiting
• Conditions: Drug Drug Interaction
• Intervention / Treatment: Drug: DWP14012; Drug: DWC202201

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Atorvastatin Peak Plasma Concentration at steady state (Cmax,ss) after DWC202201 multiple dosing	[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: up to 64 days]

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2022
• Primary Completion (Actual): March 28, 2023
• Study Completion (Anticipated): June 16, 2023

Study Registration Dates

• First Submitted: November 14, 2022
• First Submitted That Met QC Criteria: April 2, 2023
• First Posted (Estimate): April 13, 2023

Study Record Updates

• Last Update Posted (Estimate): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 2, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID 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