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

• Sponsor: Daewoong Pharmaceutical Co. LTD. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05812404
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 7.7
• Patients Per Site Per Month: 4.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Drug Drug Interaction	Drug: DWP14012; Drug: DWC202201	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Oct 26, 2022
• Actual Primary Completion Date: Mar 28, 2023
• Anticipated Study Completion Date: Jun 16, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

2. 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

1. Atorvastatin Area under the plasma concentration extrapolated to infinity at steady state (AUC,ss) after DWC202201 multiple dosing [[Time Frame: up to 64 days]]

2. Atorvastatin Time to peak drug concentration at staedy state (Tmax, ss) after DWC202201 multiple dosing [[Time Frame: up to 64 days]]

3. Atorvastatin Terminal Half-life at steady state (T1/2,ss) after DWC202201 multiple dosing [[Time Frame: up to 64 days]]

4. Atorvastatin Apparent total body clearance at steady state (CLss/F) after DWC202201 multiple dosing [[Time Frame: up to 64 days]]

5. Atorvastatin Apparent volume of distribution at steady state (Vd,ss/F) after DWC202201 multiple dosing [[Time Frame: up to 64 days]]

6. 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]]

7. Atorvastatin active metabolite Terminal Half-life at steady state (T1/2,ss) after DWC202201 multiple dosing [[Time Frame: up to 64 days]]

8. 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]]

9. Atorvastatin active metabolite Apparent volume of distribution at steady state (Vd,ss/F) after DWC202201 multiple dosing [[Time Frame: up to 64 days]]

10. Atorvastatin active metabolite metabolic ratio after DWC202201 multiple dosing [[Time Frame: up to 64 days]]

11. Fexuprazan Peak Plasma Concentration (Cmax) after DWP14012 single dosing [[Time Frame: up to 64 days]]

12. Fexuprazan Area under the plasma drug concentration-time curve from 0 to tau (AUCtau) after DWP14012 single dosing [[Time Frame: up to 64 days]]

13. Fexuprazan Area under the plasma drug concentration-time curve from 0 to infinity(AUCinf) after DWP14012 single dosing [[Time Frame: up to 64 days]]

14. Fexuprazan The time of peak concentration (Tmax) after DWP14012 single dosing [[Time Frame: up to 64 days]]

15. Fexuprazan Terminal Half-life (t1/2) after DWP14012 single dosing [[Time Frame: up to 64 days]]

16. Fexuprazan Apparent Clearance (CL/F) after DWP14012 single dosing [[Time Frame: up to 64 days]]

17. Fexuprazan Apparent Volume of Distribution After extravascular administration (Vd/F) after DWP14012 single dosing [[Time Frame: up to 64 days]]

18. Fexuprazan Peak Plasma Concentration at steady state (Cmax,ss) after DWP14012 multiple dosing [[Time Frame: up to 64 days]]

19. 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]]

20. 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]]

21. Fexuprazan Time of Maximum Concentration at steady state (Tmax,ss) after DWP14012 multiple dosing [[Time Frame: up to 64 days]]

22. Fexuprazan Terminal Half-life at steady state (t1/2,ss) after DWP14012 multiple dosing [[Time Frame: up to 64 days]]

23. Fexuprazan An estimate of the total body clearance at steady state (CL ss/F) after DWP14012 multiple dosing [[Time Frame: up to 64 days]]

24. Fexuprazan Aapparent volume of distribution after extravascular administration at steady state (Vd,ss/F) after DWP14012 multiple dosing [[Time Frame: up to 64 days]]

25. Fexuprazan Accumulation ratio after DWP14012 multiple dosing [[Time Frame: up to 64 days]]

26. Fexuprazan active metabolite Peak Plasma Concentration (Cmax) after single dosing [[Time Frame: up to 64 days]]

27. 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]]

28. Fexuprazan active metabolite Area under the plasma concentration extrapolated to infinity (AUCinf) after single dosing [[Time Frame: up to 64 days]]

29. Fexuprazan active metabolite The time of peak concentration (Tmax) after single dosing [[Time Frame: up to 64 days]]

30. Fexuprazan active metabolite metabolic ratio after single dosing [[Time Frame: up to 64 days]]

31. Fexuprazan active metabolite Peak Plasma Concentration at steady state (Cmax,ss) after multiple dosing [[Time Frame: up to 64 days]]

32. Fexuprazan active metabolite AUCtau,ss AUCinf,ss Tmax,ss metabolic ratio [[Time Frame: up to 64 days]]

33. 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]]

34. 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]]

35. Fexuprazan active metabolite The time of peak concentration at steady state (Tmax,ss) after multiple dosing [[Time Frame: up to 64 days]]

36. Fexuprazan active metabolite metabolic ratio after multiple dosing [[Time Frame: up to 64 days]]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

• Daewoong Pharmaceutical Co. LTD.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daewoong Pharmaceutical Co. LTD.
• ClinicalTrials.gov Identifier: NCT05812404
• Other Study ID Numbers: DW_DWP14012109
• First Posted: Apr 13, 2023
• Last Update Posted: Apr 13, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Apr 13, 2023