Drug-drug Interactions Between DWP14012 and Aspirin in Healthy Subjects

NCT05304845 | Completed Phase 1

• 1 other identifier: DW_DWP14012108
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Drug Interaction

Outcome Measures

Primary Outcomes (7)

• Cmax of aspirin

  Up to 21 days

• Cmax,ss of DWP14012

  Up to 13 days

• Emax

  Up to 21 days

• AUClast of aspirin

  Up to 21 days

• AUCτ,ss of DWP14012

  Up to 13 days

• time to Emax

  Up to 21 days

• AUEC

  Up to 21 days

Study Arms (2)

Cohort 1

EXPERIMENTAL

Aspirin (substrate), DWP14012 (Perpetrator)

Drug: DWP14012; Drug: Aspirin

Cohort 2

EXPERIMENTAL

DWP14012 (substrate), Aspirin (Perpetrator)

Drug: DWP14012; Drug: Aspirin

Interventions

DWP14012 DRUG

Potassium-competitive acid blocker

Cohort 1; Cohort 2

Aspirin DRUG

acetylsalicylic acid

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Interventions

fexuprazan; Aspirin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• In Jin Jang, MD, PhD

  Seoul National University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: March 31, 2022
• Study Start: March 21, 2022
• Primary Completion: May 22, 2022
• Study Completion: May 22, 2022
• Last Updated: April 5, 2023

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)