Clinical trial NCT05304845: Drug-drug Interactions Between DWP14012 and Aspirin in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Drug Interaction
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2022-03-31
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cmax of aspirin
timeFrame: Up to 21 days
measure: Cmax,ss of DWP14012
timeFrame: Up to 13 days
measure: Emax
timeFrame: Up to 21 days
measure: AUClast of aspirin
timeFrame: Up to 21 days
measure: AUCτ,ss of DWP14012
timeFrame: Up to 13 days
measure: time to Emax
timeFrame: Up to 21 days
measure: AUEC
timeFrame: Up to 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University
name: In Jin Jang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: