Healthy VolunteersPhase 1NCT03574415
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP14012 After Oral Administration in Healthy Japanese, Caucasian and Korean
A Phase 1 study testing DWP14012 in people with Healthy Volunteers, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
To evaluate the safety and tolerability of single and multiple ascending oral doses of DWP14012 in healthy Japanese, Caucasian and Korean subjects Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- DWP14012
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2018to 23 Jan 2019
- 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 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 who have been Helicobacter pylori positive
- 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
- Those who have anatomical disability in insertion and maintenance of pH meter catheter
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of DWP14012 in Healthy Japanese, Caucasian and Korean
To evaluate the safety and tolerability of single and multiple ascending oral doses of DWP14012 in healthy Japanese, Caucasian and Korean subjects
- Conditions
- Healthy Volunteers
- Being tested
- DWP14012, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP14012Drug
DWP14012 tablets
PlaceboDrug
DWP14012 placebo-matching tablets
| Study group | Role | What they receive |
|---|---|---|
| Japanese_DWP14012 Amg | Experimental | DWP14012 Amg, tablets, orally, single and multiple administration Receives: Drug: DWP14012; Drug: Placebo |
| Japanese_DWP14012 Bmg | Experimental | DWP14012 Bmg, tablets, orally, single and multiple administration Receives: Drug: DWP14012; Drug: Placebo |
| Japanese_DWP14012 Cmg | Experimental | DWP14012 Cmg, tablets, orally, single and multiple administration Receives: Drug: DWP14012; Drug: Placebo |
| Caucasian_DWP14012 Bmg | Experimental | DWP14012 Bmg, tablets, orally, single and multiple administration Receives: Drug: DWP14012; Drug: Placebo |
| Caucasian_DWP14012 Cmg | Experimental | DWP14012 Cmg, tablets, orally, single and multiple administration Receives: Drug: DWP14012; Drug: Placebo |
| Korean_DWP14012 Bmg | Experimental | DWP14012 Bmg, tablets, orally, single and multiple administration Receives: Drug: DWP14012; Drug: Placebo |
| Korean_DWP14012 Cmg | Experimental | DWP14012 Cmg, tablets, orally, single and multiple administration Receives: Drug: DWP14012; Drug: Placebo |
| Placebo | Placebo comparator | DWP14012 placebo-matching tablets Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum concentration of DWP14012
Measured: 1d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 5d~10d pre-dose, 11d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96h
Cmax,ss / Cmin,ss
Maximum / Minimum concentration of DWP14012 at steady state
Measured: 1d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 5d~10d pre-dose, 11d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96h
Tmax
Time of maximum concentration
Measured: 1d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 5d~10d pre-dose, 11d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96h
AUClast / AUCinf
Area under the plasma concentration-time curve
Measured: 1d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 5d~10d pre-dose, 11d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96h
T1/2
Elimination half-life
Measured: 1d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 5d~10d pre-dose, 11d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96h
Percentage of total time that the intragastric pH was above 4
After single administration of the investigational products, 24hr gastric pH monitoring started.
Measured: Day 1
Percentage of total time that the intragastric pH was above 4
After single administration of the investigational products, 24hr gastric pH monitoring started.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start1 Nov 2018
- Primary completion18 Jan 2019
- Study completion23 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 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
- NCT03574415
- Sponsor's protocol ID
- DW_DWP14012004
- Status last verified
- Jun 2019
- First submitted
- 20 Jun 2018
- Last updated
- 27 Jun 2019
- 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 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of DWP14012 in Healthy Japanese, Caucasian and Korean
- ClinicalTrials.gov ID
- NCT03574415
- Acronym / sponsor ID
- DW_DWP14012004
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 18 Jan 2019 (actual)
- Study completion
- 23 Jan 2019 (actual)
- First posted
- 2 Jul 2018 (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.
To evaluate the safety and tolerability of single and multiple ascending oral doses of DWP14012 in healthy Japanese, Caucasian and Korean subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Japanese_DWP14012 Amg | Experimental | Drug: DWP14012, Drug: PlaceboDWP14012 Amg, tablets, orally, single and multiple administration |
| Japanese_DWP14012 Bmg | Experimental | Drug: DWP14012, Drug: PlaceboDWP14012 Bmg, tablets, orally, single and multiple administration |
| Japanese_DWP14012 Cmg | Experimental | Drug: DWP14012, Drug: PlaceboDWP14012 Cmg, tablets, orally, single and multiple administration |
| Caucasian_DWP14012 Bmg | Experimental | Drug: DWP14012, Drug: PlaceboDWP14012 Bmg, tablets, orally, single and multiple administration |
| Caucasian_DWP14012 Cmg | Experimental | Drug: DWP14012, Drug: PlaceboDWP14012 Cmg, tablets, orally, single and multiple administration |
| Korean_DWP14012 Bmg | Experimental | Drug: DWP14012, Drug: PlaceboDWP14012 Bmg, tablets, orally, single and multiple administration |
| Korean_DWP14012 Cmg | Experimental | Drug: DWP14012, Drug: PlaceboDWP14012 Cmg, tablets, orally, single and multiple administration |
| Placebo | Placebo comparator | Drug: PlaceboDWP14012 placebo-matching tablets |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- 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 who have been Helicobacter pylori positive
- 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
- Those who have anatomical disability in insertion and maintenance of pH meter catheter
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 tablets | Drug | Caucasian_DWP14012 Bmg, Caucasian_DWP14012 Cmg, Japanese_DWP14012 Amg, Japanese_DWP14012 Bmg, Japanese_DWP14012 Cmg, Korean_DWP14012 Bmg, Korean_DWP14012 Cmg |
| PlaceboDWP14012 placebo-matching tablets | Drug | Caucasian_DWP14012 Bmg, Caucasian_DWP14012 Cmg, Japanese_DWP14012 Amg, Japanese_DWP14012 Bmg, Japanese_DWP14012 Cmg, Korean_DWP14012 Bmg, Korean_DWP14012 Cmg, Placebo |
Primary outcome
Cmax
Time frame: 1d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 5d~10d pre-dose, 11d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96h
Maximum concentration of DWP14012
Cmax,ss / Cmin,ss
Time frame: 1d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 5d~10d pre-dose, 11d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96h
Maximum / Minimum concentration of DWP14012 at steady state
Tmax
Time frame: 1d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 5d~10d pre-dose, 11d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96h
Time of maximum concentration
AUClast / AUCinf
Time frame: 1d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 5d~10d pre-dose, 11d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96h
Area under the plasma concentration-time curve
T1/2
Time frame: 1d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 5d~10d pre-dose, 11d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96h
Elimination half-life
Percentage of total time that the intragastric pH was above 4
Time frame: Day 1
After single administration of the investigational products, 24hr gastric pH monitoring started.
Percentage of total time that the intragastric pH was above 4
Time frame: Day 7
After single administration of the investigational products, 24hr gastric pH monitoring started.
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 27 Jun 2019.
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Screening Protocol
Pain
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 in people with 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 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: finished, as of the sponsor's last update on 27 Jun 2019. 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. Some participants in this study may receive a placebo. 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 (time frame: 1d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 5d~10d pre-dose, 11d pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96h). 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 27 Jun 2019.