Drug-drug Interactions Between DWP14012 and Aspirin in Healthy Subjects

Sponsor
Daewoong Pharmaceutical Co. LTD. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05304845
Collaborator
(none)
24
Enrollment
2
Arms
2
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Anticipated Study Start Date :
Mar 21, 2022
Anticipated Primary Completion Date :
May 22, 2022
Anticipated Study Completion Date :
May 22, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Cohort 1

Aspirin (substrate), DWP14012 (Perpetrator)

Drug: DWP14012
Potassium-competitive acid blocker

Drug: Aspirin
acetylsalicylic acid

Experimental: Cohort 2

DWP14012 (substrate), Aspirin (Perpetrator)

Drug: DWP14012
Potassium-competitive acid blocker

Drug: Aspirin
acetylsalicylic acid

Outcome Measures

Primary Outcome Measures

  1. Cmax of aspirin [Up to 21 days]

  2. Cmax,ss of DWP14012 [Up to 13 days]

  3. Emax [Up to 21 days]

  4. AUClast of aspirin [Up to 21 days]

  5. AUCτ,ss of DWP14012 [Up to 13 days]

  6. time to Emax [Up to 21 days]

  7. AUEC [Up to 21 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Daewoong Pharmaceutical Co. LTD.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT05304845
Other Study ID Numbers:
  • DW_DWP14012108
First Posted:
Mar 31, 2022
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022