Phase 1 Study, Healthy VolunteersPhase 1NCT05149274
Evaluate the Pharmacokinetics and Safety of DWP14012 Tablet A and Compare Those of DWP14012 Tablet B in Healthy Subjects
A Phase 1 study testing DWP14012 Tablet A and DWP14012 Tablet B in people with Phase 1 Study, Healthy Volunteers, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
The pharmacokinetics (PK) and safety of oral DWP14012 tablet A will be evaluated and compared with those of DWP14012 tablet B in healthy subjects. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Phase 1 Study, Healthy Volunteers
- What is being tested?
- DWP14012 Tablet A and DWP14012 Tablet B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2021to 26 Oct 2021
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults >=19years and <=45 years of age
- BMI >=17.5 kg/m2 and <30.5kg/m2, and body weight >= 55kg for male and >= 45kg for femlae
- subjects with no abnormal symptoms or findings based on physical examinations
- subjects determined eligible based on the results of lab tests
- subjects who agree to participate
Who cannot join
- Subjects with medical history that can not be participated
- Subjects with results of lab tests performed at screening which meet any of the following :
- ALT or AST > 1.5 times the upper limit of normal
- Diagnosis of Helicobacter pylori (H. pylori) positive result
- subject who is allergic to IP
- subject with history of serious alcohol or drug abuse within 1 year prior to screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label Study to Evaluate the Pharmacokinetics and Safety of DWP14012 Tablet A and Compare Those of DWP14012 Tablet B in Healthy Subjects
The pharmacokinetics (PK) and safety of oral DWP14012 tablet A will be evaluated and compared with those of DWP14012 tablet B in healthy subjects.
- Conditions
- Phase 1 Study, Healthy Volunteers
- Being tested
- DWP14012 Tablet A, DWP14012 Tablet B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP14012 Tablet ADrug
DWP14012 10mg
DWP14012 Tablet BDrug
DWP14012 40mg
| Study group | Role | What they receive |
|---|---|---|
| Part1 | Active comparator | DWP14012 Tablet A : single/multiple dose, 1 group, 2 period study Receives: Drug: DWP14012 Tablet A |
| Part2 | Active comparator | DWP14012 Tablet A 4T vs DWP14012 Tablet B 1T Receives: Drug: DWP14012 Tablet A; Drug: DWP14012 Tablet B |
What is being measured
The primary outcome is the main question the study is designed to answer.
(part 2) AUC last of DWP14012
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing
(part 2) Cmax of DWP14012
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing
Secondary outcomes (7)
(Part 2) AUC inf of DWP14012
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing
(Part 2) Tmax of DWP14012
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing
(Part 2) t1/2 of DWP14012
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing
(part 1-period 1) AUC last of DWP14012
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours
(part 1-period 1) Cmax of DWP14012
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours
(part 1- period 2) AUC last of DWP14012
Measured: 0 hours (pre-dose) on Day 5; 12 hours (pre-dose) on Day 7; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 (pre-dose), 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, and 48 hours after dosing on Day 8
(part 1- period 2) Cmax of DWP14012
Measured: 0 hours (pre-dose) on Day 5; 12 hours (pre-dose) on Day 7; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 (pre-dose), 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, and 48 hours after dosing on Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start1 Oct 2021
- Primary completion26 Oct 2021
- Study completion26 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phase 1 Study, Healthy 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT05149274
- Sponsor's protocol ID
- DW_DWP14012107
- Status last verified
- Nov 2021
- First submitted
- 15 Nov 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Study to Evaluate the Pharmacokinetics and Safety of DWP14012 Tablet A and Compare Those of DWP14012 Tablet B in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05149274
- Acronym / sponsor ID
- DW_DWP14012107
- Conditions
- Phase 1 Study, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 26 Oct 2021 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 8 Dec 2021 (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.
The pharmacokinetics (PK) and safety of oral DWP14012 tablet A will be evaluated and compared with those of DWP14012 tablet B in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part1 | Active comparator | Drug: DWP14012 Tablet ADWP14012 Tablet A : single/multiple dose, 1 group, 2 period study |
| Part2 | Active comparator | Drug: DWP14012 Tablet A, Drug: DWP14012 Tablet BDWP14012 Tablet A 4T vs DWP14012 Tablet B 1T |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adults >=19years and <=45 years of age
- BMI >=17.5 kg/m2 and <30.5kg/m2, and body weight >= 55kg for male and >= 45kg for femlae
- subjects with no abnormal symptoms or findings based on physical examinations
- subjects determined eligible based on the results of lab tests
- subjects who agree to participate
Key exclusion criteria (6 listed)
- Subjects with medical history that can not be participated
- Subjects with results of lab tests performed at screening which meet any of the following :
- subject who is allergic to IP
- subject with history of serious alcohol or drug abuse within 1 year prior to screening.
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 |
|---|---|---|
| DWP14012 Tablet ADWP14012 10mg | Drug | Part1, Part2 |
| DWP14012 Tablet BDWP14012 40mg | Drug | Part2 |
Primary outcome
(part 2) AUC last of DWP14012
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing
(part 2) Cmax of DWP14012
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing
7 secondary outcomes
(Part 2) AUC inf of DWP14012
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing
(Part 2) Tmax of DWP14012
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing
(Part 2) t1/2 of DWP14012
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing
(part 1-period 1) AUC last of DWP14012
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours
(part 1-period 1) Cmax of DWP14012
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours
(part 1- period 2) AUC last of DWP14012
Time frame: 0 hours (pre-dose) on Day 5; 12 hours (pre-dose) on Day 7; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 (pre-dose), 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, and 48 hours after dosing on Day 8
(part 1- period 2) Cmax of DWP14012
Time frame: 0 hours (pre-dose) on Day 5; 12 hours (pre-dose) on Day 7; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 (pre-dose), 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, and 48 hours after dosing on Day 8
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 8 Dec 2021.
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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 Tablet A and DWP14012 Tablet B in people with Phase 1 Study, Healthy 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 5 inclusion and 6 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 8 Dec 2021. 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?
(part 2) AUC last of DWP14012 (time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing). 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 8 Dec 2021.