Drug-drug InteractionPhase 1DWJ1610NCT05699070
Drug-drug Interactions Between DWC202211 and DWC202212 in Healthy Subjects
A Phase 1 study testing DWC202211 100mg, DWC202212 5mg and DWC202211 100mg + DWC202212 5mg in people with Drug-drug Interaction, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
An open-label phase 1 study to evaluate pharmacokinetic/pharmacodynamic drug-drug interactions and safety/tolerability of DWC202211 and DWC202212 compared to coadministration in healthy 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?
- DWC202211 100mg, DWC202212 5mg and DWC202211 100mg + DWC202212 5mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Feb 2023to 1 Jun 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
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Phase 1 Study to Evaluate Pharmacokinetic/Pharmacodynamic Drug-drug Interactions and Safety/Tolerability of DWC202211 and DWC202212 Compared to Coadministration in Healthy
An open-label phase 1 study to evaluate pharmacokinetic/pharmacodynamic drug-drug interactions and safety/tolerability of DWC202211 and DWC202212 compared to coadministration in healthy
- Conditions
- Drug-drug Interaction
- Being tested
- DWC202211 100mg, DWC202212 5mg, DWC202211 100mg + DWC202212 5mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWC202211 100mgDrug
DWC202211 for 5 days
Aspirin 100mg
DWC202212 5mgDrug
DWC202212 for 3 days
Rabeprazole 5mg
DWC202211 100mg + DWC202212 5mgDrug
DWC202211 + DWC202212 for 5 days
Aspirin 100mg, Rabeprazole 5mg
| Study group | Role | What they receive |
|---|---|---|
| DWC202211 | Experimental | Not described Receives: Drug: DWC202211 100mg |
| DWC202212 | Experimental | Not described Receives: Drug: DWC202212 5mg |
| DWC202211 + DWC202212 | Experimental | Not described Receives: Drug: DWC202211 100mg + DWC202212 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Measured: up to 27 days
AUClast
Measured: up to 27 days
Secondary outcomes (14)
DWC202211 Tmax,ss
Measured: up to 27 days
DWC202211 T1/2,ss
Measured: up to 27 days
DWC202211 Cmin,ss
Measured: up to 27 days
DWC202211 Cavg,ss
Measured: up to 27 days
DWC202211 CLss/F
Measured: up to 27 days
DWC202211 Vdss/f
Measured: up to 27 days
DWC202211 PTF
Measured: up to 27 days
DWC202212 Tmax,ss
Measured: up to 27 days
DWC202212 T1/2,ss
Measured: up to 27 days
DWC202212 Cmin,ss
Measured: up to 27 days
DWC202212 Cavg,ss
Measured: up to 27 days
DWC202212 CLss/F
Measured: up to 27 days
DWC202212 Vdss/f
Measured: up to 27 days
DWC202212 PTF
Measured: up to 27 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start15 Feb 2023
- Primary completion24 Apr 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
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
- NCT05699070
- Sponsor's protocol ID
- DW_DWJ1610101
- Acronym
- DWJ1610
- Status last verified
- Jan 2023
- First submitted
- 10 Jan 2023
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- An Open-label Phase 1 Study to Evaluate Pharmacokinetic/Pharmacodynamic Drug-drug Interactions and Safety/Tolerability of DWC202211 and DWC202212 Compared to Coadministration in Healthy
- ClinicalTrials.gov ID
- NCT05699070
- Acronym / sponsor ID
- DWJ1610 / DW_DWJ1610101
- Conditions
- Drug-drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 24 Apr 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 26 Jan 2023 (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.
An open-label phase 1 study to evaluate pharmacokinetic/pharmacodynamic drug-drug interactions and safety/tolerability of DWC202211 and DWC202212 compared to coadministration in healthy
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DWC202211 | Experimental | Drug: DWC202211 100mg |
| DWC202212 | Experimental | Drug: DWC202212 5mg |
| DWC202211 + DWC202212 | Experimental | Drug: DWC202211 100mg + DWC202212 5mg |
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 (0 listed)
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 |
|---|---|---|
| DWC202211 100mgDWC202211 for 5 days Aspirin 100mg | Drug | DWC202211 |
| DWC202212 5mgDWC202212 for 3 days Rabeprazole 5mg | Drug | DWC202212 |
| DWC202211 100mg + DWC202212 5mgDWC202211 + DWC202212 for 5 days Aspirin 100mg, Rabeprazole 5mg | Drug | DWC202211 + DWC202212 |
Primary outcome
Cmax
Time frame: up to 27 days
AUClast
Time frame: up to 27 days
14 secondary outcomes
DWC202211 Tmax,ss
Time frame: up to 27 days
DWC202211 T1/2,ss
Time frame: up to 27 days
DWC202211 Cmin,ss
Time frame: up to 27 days
DWC202211 Cavg,ss
Time frame: up to 27 days
DWC202211 CLss/F
Time frame: up to 27 days
DWC202211 Vdss/f
Time frame: up to 27 days
DWC202211 PTF
Time frame: up to 27 days
DWC202212 Tmax,ss
Time frame: up to 27 days
DWC202212 T1/2,ss
Time frame: up to 27 days
DWC202212 Cmin,ss
Time frame: up to 27 days
DWC202212 Cavg,ss
Time frame: up to 27 days
DWC202212 CLss/F
Time frame: up to 27 days
DWC202212 Vdss/f
Time frame: up to 27 days
DWC202212 PTF
Time frame: up to 27 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
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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 DWC202211 100mg, DWC202212 5mg and DWC202211 100mg + DWC202212 5mg 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 0 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: status not confirmed, 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?
Results are not available in the source record.
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 (time frame: up to 27 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.