Healthy Male VolunteersPhase 1NCT04490434
Drug-drug Interaction Between DWP14012 and Three Different Kinds of NSAIDs
A Phase 1 study testing DWP14012, Celecoxib and Naproxen in people with Healthy Male Volunteers, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
drug-drug interaction between DWP14012 and three different kinds of NSAIDs Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers
- What is being tested?
- DWP14012, Celecoxib and Naproxen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Jun 2020to 30 Nov 2020
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult Caucasian or Japanese or Korean aged 19 to 50 (inclusive) years, at the time of screening.
- Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.
Who cannot join
- Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
- Those who have gastrointestinal diseases or past history of gastrointestinal diseases (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux, Crohn's disease etc.) that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple appendectomy and herniotomy)
- Those whose plasma AST (SGOT) and ALT (SGPT) exceed 1.5 times to the upper limit of the normal range in screening including additional examinations prior to randomization
- Subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration
- Subjects who have donated a unit of whole blood within two months or blood components within one month prior to study drug administration
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
In-Jin Jang, MD, Ph.D
About this study
Official title: A Randomized, Open-label, Multiple-dose Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic Drug-drug Interaction Between DWP14012 and Three Different Kinds of NSAIDs in Healthy Male Volunteers
drug-drug interaction between DWP14012 and three different kinds of NSAIDs
Read the detailed description
to evaluate the safety/tolerability and pharmacokinetic drug-drug interaction between DWP14012 and three different kinds of NSAIDs in healthy male volunteers
- Conditions
- Healthy Male Volunteers
- Being tested
- DWP14012, Celecoxib, Naproxen, Meloxicam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP14012Drug
DWP14012 40mg, bid
CelecoxibDrug
Celecoxib 200mg, bid
NaproxenDrug
Naproxen 500mg, bid
MeloxicamDrug
Meloxicam 15mg, qd
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1, A (DWP14012/Celecoxib) | Experimental | Patients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated. Receives: Drug: DWP14012; Drug: Celecoxib |
| Cohort 1, B (DWP14012/Celecoxib) | Experimental | Patients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated. Receives: Drug: DWP14012; Drug: Celecoxib |
| Cohort 2, C (DWP14012/Naproxen) | Experimental | Patients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated. Receives: Drug: DWP14012; Drug: Naproxen |
| Cohort 2, D (DWP14012/Naproxen) | Experimental | Patients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated. Receives: Drug: DWP14012; Drug: Naproxen |
| Cohort 3, E (DWP14012/Meloxicam) | Experimental | Patients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated. Receives: Drug: DWP14012; Drug: Meloxicam |
| Cohort 3, F (DWP14012/Meloxicam) | Experimental | Patients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated. Receives: Drug: DWP14012; Drug: Meloxicam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm A, Cmax,ss of Celecoxib
Maximum measured plasma concentration at steady-state
Measured: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
Arm A, AUCτ,ss of Celecoxib
Area under the plasma concentration-time curve
Measured: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
Arm B, Cmax,ss of DWP14012
Maximum measured plasma concentration at steady-state
Measured: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
Arm B, AUCτ,ss of DWP14012
Area under the plasma concentration-time curve
Measured: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
Arm C, Cmax,ss of Naproxen
Maximum measured plasma concentration at steady-state
Measured: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
Arm C, AUCτ,ss of Naproxen
Area under the plasma concentration-time curve
Measured: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
Arm D, Cmax,ss of DWP14012
Maximum measured plasma concentration at steady-state
Measured: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
Arm D, AUCτ,ss of DWP14012
Area under the plasma concentration-time curve
Measured: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
Arm E, Cmax,ss of Meloxicam
Maximum measured plasma concentration at steady-state
Measured: Day 7,(0 hours (pre-dose), 1~72 hours) / Day 16,(0 hours (pre-dose), 1~72 hours)
Arm E, AUCτ,ss of Meloxicam
Area under the plasma concentration-time curve
Measured: Day 7,(0 hours (pre-dose), 1~72 hours) / Day 16,(0 hours (pre-dose), 1~72 hours)
Arm D, Cmax,ss of DWP14012
Maximum measured plasma concentration at steady-state
Measured: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 13,(0 hours (pre-dose), 0.5~48 hours)
Arm D, AUCτ,ss of DWP14012
Area under the plasma concentration-time curve
Measured: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 13,(0 hours (pre-dose), 0.5~48 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start19 Jun 2020
- Primary completion31 Aug 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Male VolunteersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jang In-Jin, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490434
- Sponsor's protocol ID
- DW_DWP14012005
- Status last verified
- Jul 2020
- First submitted
- 24 Apr 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Won H, Kim E, Chae J, Lee H, Cho JY, Jang IJ, Chung JY, Kim MG, Lee S. Pharmacokinetic interactions between fexuprazan, a potassium-competitive acid blocker, and nonsteroidal anti-inflammatory drugs in healthy males. Clin Transl Sci. 2024 May;17(5):e13798. doi: 10.1111/cts.13798.
PubMed 38700290
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multiple-dose Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic Drug-drug Interaction Between DWP14012 and Three Different Kinds of NSAIDs in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT04490434
- Acronym / sponsor ID
- DW_DWP14012005
- Conditions
- Healthy Male Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 29 Jul 2020 (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.
drug-drug interaction between DWP14012 and three different kinds of NSAIDs
Detailed description
to evaluate the safety/tolerability and pharmacokinetic drug-drug interaction between DWP14012 and three different kinds of NSAIDs in healthy male volunteers
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1, A (DWP14012/Celecoxib) | Experimental | Drug: DWP14012, Drug: CelecoxibPatients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated. |
| Cohort 1, B (DWP14012/Celecoxib) | Experimental | Drug: DWP14012, Drug: CelecoxibPatients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated. |
| Cohort 2, C (DWP14012/Naproxen) | Experimental | Drug: DWP14012, Drug: NaproxenPatients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated. |
| Cohort 2, D (DWP14012/Naproxen) | Experimental | Drug: DWP14012, Drug: NaproxenPatients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated. |
| Cohort 3, E (DWP14012/Meloxicam) | Experimental | Drug: DWP14012, Drug: MeloxicamPatients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated. |
| Cohort 3, F (DWP14012/Meloxicam) | Experimental | Drug: DWP14012, Drug: MeloxicamPatients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adult Caucasian or Japanese or Korean aged 19 to 50 (inclusive) years, at the time of screening.
- Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.
Key exclusion criteria (5 listed)
- Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
- Those who have gastrointestinal diseases or past history of gastrointestinal diseases (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux, Crohn's disease etc.) that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple appendectomy and herniotomy)
- Those whose plasma AST (SGOT) and ALT (SGPT) exceed 1.5 times to the upper limit of the normal range in screening including additional examinations prior to randomization
- Subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration
- Subjects who have donated a unit of whole blood within two months or blood components within one month prior to study drug administration
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 |
|---|---|---|
| DWP14012DWP14012 40mg, bid | Drug | Cohort 1, A (DWP14012/Celecoxib), Cohort 1, B (DWP14012/Celecoxib), Cohort 2, C (DWP14012/Naproxen), Cohort 2, D (DWP14012/Naproxen), Cohort 3, E (DWP14012/Meloxicam), Cohort 3, F (DWP14012/Meloxicam) |
| CelecoxibCelecoxib 200mg, bid | Drug | Cohort 1, A (DWP14012/Celecoxib), Cohort 1, B (DWP14012/Celecoxib) |
| NaproxenNaproxen 500mg, bid | Drug | Cohort 2, C (DWP14012/Naproxen), Cohort 2, D (DWP14012/Naproxen) |
| MeloxicamMeloxicam 15mg, qd | Drug | Cohort 3, E (DWP14012/Meloxicam), Cohort 3, F (DWP14012/Meloxicam) |
Primary outcome
Arm A, Cmax,ss of Celecoxib
Time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
Maximum measured plasma concentration at steady-state
Arm A, AUCτ,ss of Celecoxib
Time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
Area under the plasma concentration-time curve
Arm B, Cmax,ss of DWP14012
Time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
Maximum measured plasma concentration at steady-state
Arm B, AUCτ,ss of DWP14012
Time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
Area under the plasma concentration-time curve
Arm C, Cmax,ss of Naproxen
Time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
Maximum measured plasma concentration at steady-state
Arm C, AUCτ,ss of Naproxen
Time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
Area under the plasma concentration-time curve
Arm D, Cmax,ss of DWP14012
Time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
Maximum measured plasma concentration at steady-state
Arm D, AUCτ,ss of DWP14012
Time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
Area under the plasma concentration-time curve
Arm E, Cmax,ss of Meloxicam
Time frame: Day 7,(0 hours (pre-dose), 1~72 hours) / Day 16,(0 hours (pre-dose), 1~72 hours)
Maximum measured plasma concentration at steady-state
Arm E, AUCτ,ss of Meloxicam
Time frame: Day 7,(0 hours (pre-dose), 1~72 hours) / Day 16,(0 hours (pre-dose), 1~72 hours)
Area under the plasma concentration-time curve
Arm D, Cmax,ss of DWP14012
Time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 13,(0 hours (pre-dose), 0.5~48 hours)
Maximum measured plasma concentration at steady-state
Arm D, AUCτ,ss of DWP14012
Time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 13,(0 hours (pre-dose), 0.5~48 hours)
Area under the plasma concentration-time curve
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Derived from this study: PubMed 38700290Won H, Kim E, Chae J, Lee H, Cho JY, Jang IJ, Chung JY, Kim MG, Lee S. Pharmacokinetic interactions between fexuprazan, a potassium-competitive acid blocker, and nonsteroidal anti-inflammatory drugs in healthy males. Clin Transl Sci. 2024 May;17(5):e13798. doi: 10.1111/cts.13798.
- 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.
Jang In-Jin, MD, PhD principal investigator
Seoul National University Hospital
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, Celecoxib and Naproxen in people with Healthy Male Volunteers, 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 2 inclusion and 5 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 29 Jul 2020. 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?
Contact Jang In-Jin, MD, PhD (+82-2-2072-1910, ijjang@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arm A, Cmax,ss of Celecoxib (time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04490434, which also lists 1 linked publication.
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 29 Jul 2020.