Drug-drug Interactions Between DWP14012 and Aspirin in Healthy Subjects

Drug Drug Interaction Clinical Trial

Official title:

A Randomized, Open-label Study to Evaluate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of Drug-drug Interactions Between DWP14012 and Aspirin in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05304845
• Other study ID #: DW_DWP14012108
• Status: Completed
• Phase: Phase 1
• Start date: March 21, 2022
• Est. completion date: May 22, 2022

Study information

• Verified date: March 2022
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 22, 2022
• Est. primary completion date: May 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Drug Interaction

Intervention

Drug:
• DWP14012
Potassium-competitive acid blocker
• Aspirin
acetylsalicylic acid

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of aspirin		Up to 21 days
Primary	Cmax,ss of DWP14012		Up to 13 days
Primary	Emax		Up to 21 days
Primary	AUClast of aspirin		Up to 21 days
Primary	AUCt,ss of DWP14012		Up to 13 days
Primary	time to Emax		Up to 21 days
Primary	AUEC		Up to 21 days