Drug-drug Interactions Between DWP14012 and Aspirin in Healthy Subjects

Phase 1

Completed

• Conditions: Drug Drug Interaction
• Interventions: Drug: DWP14012; Drug: Aspirin

• Registration Number: NCT05304845
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

This is a randomized, open-label study to evaluate the safety/tolerability and PK/PD drug-drug interactions between DWP14012 and aspirin when administered in combination.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-16
• Study Start: 2022-03-21
• Study First Submitted QC: 2022-03-28
• Study First Posted: 2022-03-31
• Primary Completion: 2022-05-22
• Study Completion: 2022-05-22
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

• For women, negative urine pregnancy test (hCG) at the screening visit

Exclusion Criteria

• Subjects with hypersensitivity or history of clinically significant hypersensitivity to drugs including potassium competitive acid blocker [P-CAB] class, aspirin, salicylic acid, or other drugs (non-steroidal anti-inflammatory drug [NSAIDs], antibiotics, etc.)
• Women who are or may be pregnant, or are breast-feeding
• Subjects with a history related to blood clotting disorder or bleeding
• Subjects with a medical diagnosis of functional constipation
• 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, and disagreed to refrain from donating sperms during this period
• Subjects with hereditary disorders including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2	DWP14012	DWP14012 (substrate), Aspirin (Perpetrator)
Cohort 2	Aspirin	DWP14012 (substrate), Aspirin (Perpetrator)
Cohort 1	DWP14012	Aspirin (substrate), DWP14012 (Perpetrator)
Cohort 1	Aspirin	Aspirin (substrate), DWP14012 (Perpetrator)

Primary Outcome Measures

Name	Time	Method
time to Emax	Up to 21 days
Cmax,ss of DWP14012	Up to 13 days
AUCτ,ss of DWP14012	Up to 13 days
AUEC	Up to 21 days
Cmax of aspirin	Up to 21 days
Emax	Up to 21 days
AUClast of aspirin	Up to 21 days

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of