Drug Drug InteractionPhase 1NCT05304845
Drug-drug Interactions Between DWP14012 and Aspirin in Healthy Subjects
A Phase 1 study testing DWP14012 and Aspirin in people with Drug Drug Interaction, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Drug Interaction
- What is being tested?
- DWP14012 and Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Mar 2022to 22 May 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- DWP14012, Aspirin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP14012Drug
Potassium-competitive acid blocker
AspirinDrug
acetylsalicylic acid
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Aspirin (substrate), DWP14012 (Perpetrator) Receives: Drug: DWP14012; Drug: Aspirin |
| Cohort 2 | Experimental | DWP14012 (substrate), Aspirin (Perpetrator) Receives: Drug: DWP14012; Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of aspirin
Measured: Up to 21 days
Cmax,ss of DWP14012
Measured: Up to 13 days
Emax
Measured: Up to 21 days
AUClast of aspirin
Measured: Up to 21 days
AUCτ,ss of DWP14012
Measured: Up to 13 days
time to Emax
Measured: Up to 21 days
AUEC
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start21 Mar 2022
- Primary completion22 May 2022
- Study completion22 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Drug InteractionStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- In Jin Jang, MD, PhD, Principal investigator, Seoul National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304845
- Sponsor's protocol ID
- DW_DWP14012108
- Status last verified
- Mar 2022
- First submitted
- 16 Mar 2022
- Last updated
- 5 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05304845
- Acronym / sponsor ID
- DW_DWP14012108
- Conditions
- Drug Drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 22 May 2022 (actual)
- Study completion
- 22 May 2022 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: DWP14012, Drug: AspirinAspirin (substrate), DWP14012 (Perpetrator) |
| Cohort 2 | Experimental | Drug: DWP14012, Drug: AspirinDWP14012 (substrate), Aspirin (Perpetrator) |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DWP14012Potassium-competitive acid blocker | Drug | Cohort 1, Cohort 2 |
| Aspirinacetylsalicylic acid | Drug | Cohort 1, Cohort 2 |
Primary outcome
Cmax of aspirin
Time frame: Up to 21 days
Cmax,ss of DWP14012
Time frame: Up to 13 days
Emax
Time frame: Up to 21 days
AUClast of aspirin
Time frame: Up to 21 days
AUCτ,ss of DWP14012
Time frame: Up to 13 days
time to Emax
Time frame: Up to 21 days
AUEC
Time frame: Up to 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In Jin Jang, MD, PhD principal investigator
Seoul National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DWP14012 and Aspirin in people with Drug Drug Interaction, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of aspirin (time frame: Up to 21 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.