Drug Drug InteractionPhase 1NCT05574374
Drug-drug Interactions Between DWP14012 and DWC202202 in Healthy Subjects
A Phase 1 study testing DWP14012, DWC202202 and DWC202203 in people with Drug Drug Interaction, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
A randomized, open-label, three-sequence, three-period, multiple dosing crossover, phase 1 clinical trial to evaluate the effect of DWP14012 on the pharmacodynamics of DWC202202 in combination with DWP14012 in healthy subjects 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, DWC202202 and DWC202203
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Sep 2022to 6 Mar 2023
- 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.
Who cannot join
- Subjects with a history related to blood clotting disorder or bleeding
- Subjects with hypersensitivity or history of clinically significant hypersensitivity to drugs including potassium competitive acid blocker [P-CAB] class, aspirin, antibiotics, etc.
- 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
Show all 9Show fewer
- Subjects with hereditary disorders including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
- 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
- Subjects who are smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Three-sequence, Three-period, Multiple Dosing Crossover, Phase 1 Clinical Trial to Evaluate the Effect of DWP14012 on the Pharmacodynamics of DWC202202 in Combination With DWP14012 in Healthy Subjects
A randomized, open-label, three-sequence, three-period, multiple dosing crossover, phase 1 clinical trial to evaluate the effect of DWP14012 on the pharmacodynamics of DWC202202 in combination with DWP14012 in healthy subjects
- Conditions
- Drug Drug Interaction
- Being tested
- DWP14012, DWC202202, DWC202203
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP14012Drug
Potassium-competitive acid blocker
DWC202202Drug
Clopidogrel Bisulfate
DWC202203Drug
Proton pump inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | * Treatment A: DWC202202 1 tablet qd for 7days
* Treatment B: DWC202202 1 tablet qd + DWP14012 1 tablet qd for 7days
* Treatment C: DWC202202 1 tablet qd + DWC202203 1 tablet qd for 7days Receives: Drug: DWP14012; Drug: DWC202202; Drug: DWC202203 |
| Cohort 2 | Experimental | * Treatment C: DWC202202 1 tablet qd + DWC202203 1 tablet qd for 7days
* Treatment A: DWC202202 1 tablet qd for 7days
* Treatment B: DWC202202 1 tablet qd + DWP14012 1 tablet qd for 7days Receives: Drug: DWP14012; Drug: DWC202202; Drug: DWC202203 |
| Cohort 3 | Experimental | * Treatment B: DWC202202 1 tablet qd + DWP14012 1 tablet qd for 7days
* Treatment C: DWC202202 1 tablet qd + DWC202203 1 tablet qd for 7days
* Treatment A: DWC202202 1 tablet qd for 7days Receives: Drug: DWP14012; Drug: DWC202202; Drug: DWC202203 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emax
Measured: up to 50 days
AUEC0-24
Measured: up to 50 days
Secondary outcomes (20)
DWC202202 Cmax,ss
Measured: up to 50 days
DWC202202 active metabolite Cmax,ss
Measured: up to 50 days
DWC202202 AUCtau,ss
Measured: up to 50 days
DWC202202 active metabolite AUCtau,ss
Measured: up to 50 days
DWC202202 AUCinf,ss
Measured: up to 50 days
DWC202202 active metabolite AUCinf,ss
Measured: up to 50 days
DWC202202 Tmax,ss
Measured: up to 50 days
DWC202202 active metabolite Tmax,ss
Measured: up to 50 days
DWC202202 t1/2,ss
Measured: up to 50 days
DWC202202 active metabolite t1/2,ss
Measured: up to 50 days
DWC202202 Cmin,ss
Measured: up to 50 days
DWC202202 active metabolite Cmin,ss
Measured: up to 50 days
DWC202202 Cavg,ss
Measured: up to 50 days
DWC202202 active metabolite Cavg,ss
Measured: up to 50 days
DWC202202 CLss/F
Measured: up to 50 days
DWC202202 Vd,ss/F
Measured: up to 50 days
DWC202202 PTF (peak to trough fluctuation)
Measured: up to 50 days
DWC202202 active metabolite PTF (peak to trough fluctuation)
Measured: up to 50 days
DWC202202 R
Measured: up to 50 days
DWC202202 active metabolite MR
Measured: up to 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start21 Sep 2022
- Primary completion6 Mar 2023
- Study completion6 Mar 2023
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574374
- Sponsor's protocol ID
- DW_DWP14012110
- Status last verified
- Apr 2023
- First submitted
- 4 Sep 2022
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Three-sequence, Three-period, Multiple Dosing Crossover, Phase 1 Clinical Trial to Evaluate the Effect of DWP14012 on the Pharmacodynamics of DWC202202 in Combination With DWP14012 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05574374
- Acronym / sponsor ID
- DW_DWP14012110
- Conditions
- Drug Drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 6 Mar 2023 (actual)
- Study completion
- 6 Mar 2023 (actual)
- First posted
- 10 Oct 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.
A randomized, open-label, three-sequence, three-period, multiple dosing crossover, phase 1 clinical trial to evaluate the effect of DWP14012 on the pharmacodynamics of DWC202202 in combination with DWP14012 in healthy subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: DWP14012, Drug: DWC202202, Drug: DWC202203* Treatment A: DWC202202 1 tablet qd for 7days * Treatment B: DWC202202 1 tablet qd + DWP14012 1 tablet qd for 7days * Treatment C: DWC202202 1 tablet qd + DWC202203 1 tablet qd for 7days |
| Cohort 2 | Experimental | Drug: DWP14012, Drug: DWC202202, Drug: DWC202203* Treatment C: DWC202202 1 tablet qd + DWC202203 1 tablet qd for 7days * Treatment A: DWC202202 1 tablet qd for 7days * Treatment B: DWC202202 1 tablet qd + DWP14012 1 tablet qd for 7days |
| Cohort 3 | Experimental | Drug: DWP14012, Drug: DWC202202, Drug: DWC202203* Treatment B: DWC202202 1 tablet qd + DWP14012 1 tablet qd for 7days * Treatment C: DWC202202 1 tablet qd + DWC202203 1 tablet qd for 7days * Treatment A: DWC202202 1 tablet qd for 7days |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 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 (9 listed)
- Subjects with a history related to blood clotting disorder or bleeding
- Subjects with hypersensitivity or history of clinically significant hypersensitivity to drugs including potassium competitive acid blocker [P-CAB] class, aspirin, antibiotics, etc.
- 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
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, Cohort 3 |
| DWC202202Clopidogrel Bisulfate | Drug | Cohort 1, Cohort 2, Cohort 3 |
| DWC202203Proton pump inhibitor | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Emax
Time frame: up to 50 days
AUEC0-24
Time frame: up to 50 days
20 secondary outcomes
DWC202202 Cmax,ss
Time frame: up to 50 days
DWC202202 active metabolite Cmax,ss
Time frame: up to 50 days
DWC202202 AUCtau,ss
Time frame: up to 50 days
DWC202202 active metabolite AUCtau,ss
Time frame: up to 50 days
DWC202202 AUCinf,ss
Time frame: up to 50 days
DWC202202 active metabolite AUCinf,ss
Time frame: up to 50 days
DWC202202 Tmax,ss
Time frame: up to 50 days
DWC202202 active metabolite Tmax,ss
Time frame: up to 50 days
DWC202202 t1/2,ss
Time frame: up to 50 days
DWC202202 active metabolite t1/2,ss
Time frame: up to 50 days
DWC202202 Cmin,ss
Time frame: up to 50 days
DWC202202 active metabolite Cmin,ss
Time frame: up to 50 days
DWC202202 Cavg,ss
Time frame: up to 50 days
DWC202202 active metabolite Cavg,ss
Time frame: up to 50 days
DWC202202 CLss/F
Time frame: up to 50 days
DWC202202 Vd,ss/F
Time frame: up to 50 days
DWC202202 PTF (peak to trough fluctuation)
Time frame: up to 50 days
DWC202202 active metabolite PTF (peak to trough fluctuation)
Time frame: up to 50 days
DWC202202 R
Time frame: up to 50 days
DWC202202 active metabolite MR
Time frame: up to 50 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 4 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, DWC202202 and DWC202203 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 5 inclusion and 9 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 4 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?
Emax (time frame: up to 50 days). The study lists 2 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 4 Apr 2023.