Drug-drug Interactions Between DWP14012 and Aspirin in Healthy Subjects

Daewoong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Drug Drug Interaction

Treatments: Drug: Aspirin; Drug: DWP14012

Study type: Interventional

Funder types: Industry

Identifiers

NCT05304845

DW_DWP14012108

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Cohort 1

Experimental group

Description:

Aspirin (substrate), DWP14012 (Perpetrator)

Treatment:

Drug: Aspirin

Drug: DWP14012

Cohort 2

Experimental group

Description:

DWP14012 (substrate), Aspirin (Perpetrator)

Treatment:

Drug: Aspirin

Drug: DWP14012