DWJ1610: Drug-drug Interactions Between DWC202211 and DWC202212 in Healthy Subjects

• Sponsor: Daewoong Pharmaceutical Co. LTD. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05699070
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 3.5
• Patients Per Site Per Month: 6.9

Study Details

Study Description

Brief Summary

An open-label phase 1 study to evaluate pharmacokinetic/pharmacodynamic drug-drug interactions and safety/tolerability of DWC202211 and DWC202212 compared to coadministration in healthy

Condition or Disease	Intervention/Treatment	Phase
Drug-drug Interaction	Drug: DWC202211 100mg; Drug: DWC202212 5mg; Drug: DWC202211 100mg + DWC202212 5mg	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label Phase 1 Study to Evaluate Pharmacokinetic/Pharmacodynamic Drug-drug Interactions and Safety/Tolerability of DWC202211 and DWC202212 Compared to Coadministration in Healthy
• Anticipated Study Start Date: Feb 15, 2023
• Anticipated Primary Completion Date: Apr 24, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DWC202211	Drug: DWC202211 100mg; DWC202211 for 5 days Aspirin 100mg
Experimental: DWC202212	Drug: DWC202212 5mg; DWC202212 for 3 days Rabeprazole 5mg
Experimental: DWC202211 + DWC202212	Drug: DWC202211 100mg + DWC202212 5mg; DWC202211 + DWC202212 for 5 days Aspirin 100mg, Rabeprazole 5mg

Outcome Measures

Primary Outcome Measures

1. Cmax [up to 27 days]

2. AUClast [up to 27 days]

Secondary Outcome Measures

1. DWC202211 Tmax,ss [up to 27 days]

2. DWC202211 T1/2,ss [up to 27 days]

3. DWC202211 Cmin,ss [up to 27 days]

4. DWC202211 Cavg,ss [up to 27 days]

5. DWC202211 CLss/F [up to 27 days]

6. DWC202211 Vdss/f [up to 27 days]

7. DWC202211 PTF [up to 27 days]

8. DWC202212 Tmax,ss [up to 27 days]

9. DWC202212 T1/2,ss [up to 27 days]

10. DWC202212 Cmin,ss [up to 27 days]

11. DWC202212 Cavg,ss [up to 27 days]

12. DWC202212 CLss/F [up to 27 days]

13. DWC202212 Vdss/f [up to 27 days]

14. DWC202212 PTF [up to 27 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.

Contacts and Locations

Locations

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

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: NCT05699070
• Other Study ID Numbers: DW_DWJ1610101
• First Posted: Jan 26, 2023
• Last Update Posted: Jan 26, 2023
• Last Verified: Jan 1, 2023

• 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 Jan 26, 2023