Drug-drug Interactions Between DWP14012 and DWC202202 in Healthy Subjects

A Randomized, Open-label, Three-sequence, Three-period, Multiple Dosing Crossover, Phase 1 Clinical Trial to Evaluate the Effect of DWP14012 on the Pharmacodynamics of DWC202202 in Combination With DWP14012 in Healthy Subjects

A randomized, open-label, three-sequence, three-period, multiple dosing crossover, phase 1 clinical trial to evaluate the effect of DWP14012 on the pharmacodynamics of DWC202202 in combination with DWP14012 in healthy subjects

Study Overview

• Status: Completed
• Conditions: Drug Drug Interaction
• Intervention / Treatment: Drug: DWP14012; Drug: DWC202202; Drug: DWC202203

• Study Type: Interventional
• Enrollment (Actual): 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: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

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 history related to blood clotting disorder or bleeding
• Subjects with hypersensitivity or history of clinically significant hypersensitivity to drugs including potassium competitive acid blocker [P-CAB] class, aspirin, antibiotics, etc.
• 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 with hereditary disorders including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
• 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 smoking

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: DWC202202 1 tablet qd for 7days; Treatment B: DWC202202 1 tablet qd + DWP14012 1 tablet qd for 7days; Treatment C: DWC202202 1 tablet qd + DWC202203 1 tablet qd for 7days	Drug: DWP14012; Potassium-competitive acid blocker; Drug: DWC202202; Clopidogrel Bisulfate; Drug: DWC202203; Proton pump inhibitor
Experimental: Cohort 2; Treatment C: DWC202202 1 tablet qd + DWC202203 1 tablet qd for 7days; Treatment A: DWC202202 1 tablet qd for 7days; Treatment B: DWC202202 1 tablet qd + DWP14012 1 tablet qd for 7days	Drug: DWP14012; Potassium-competitive acid blocker; Drug: DWC202202; Clopidogrel Bisulfate; Drug: DWC202203; Proton pump inhibitor
Experimental: Cohort 3; Treatment B: DWC202202 1 tablet qd + DWP14012 1 tablet qd for 7days; Treatment C: DWC202202 1 tablet qd + DWC202203 1 tablet qd for 7days; Treatment A: DWC202202 1 tablet qd for 7days	Drug: DWP14012; Potassium-competitive acid blocker; Drug: DWC202202; Clopidogrel Bisulfate; Drug: DWC202203; Proton pump inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Emax	up to 50 days
AUEC0-24	up to 50 days

Secondary Outcome Measures

Outcome Measure	Time Frame
DWC202202 Cmax,ss	up to 50 days
DWC202202 active metabolite Cmax,ss	up to 50 days
DWC202202 AUCtau,ss	up to 50 days
DWC202202 active metabolite AUCtau,ss	up to 50 days
DWC202202 AUCinf,ss	up to 50 days
DWC202202 active metabolite AUCinf,ss	up to 50 days
DWC202202 Tmax,ss	up to 50 days
DWC202202 active metabolite Tmax,ss	up to 50 days
DWC202202 t1/2,ss	up to 50 days
DWC202202 active metabolite t1/2,ss	up to 50 days
DWC202202 Cmin,ss	up to 50 days
DWC202202 active metabolite Cmin,ss	up to 50 days
DWC202202 Cavg,ss	up to 50 days
DWC202202 active metabolite Cavg,ss	up to 50 days
DWC202202 CLss/F	up to 50 days
DWC202202 Vd,ss/F	up to 50 days
DWC202202 PTF (peak to trough fluctuation)	up to 50 days
DWC202202 active metabolite PTF (peak to trough fluctuation)	up to 50 days
DWC202202 R	up to 50 days
DWC202202 active metabolite MR	up to 50 days

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2022
• Primary Completion (Actual): March 6, 2023
• Study Completion (Actual): March 6, 2023

Study Registration Dates

• First Submitted: September 4, 2022
• First Submitted That Met QC Criteria: October 6, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: DW_DWP14012110

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
• product manufactured in and exported from the U.S.: No