HealthyPhase 1NCT04167267
Pharmacokinetics and Safety of DWP14012 Tablet A and Tablet B in Healthy Volunteers (II)
A Phase 1 study testing DWP14012 tablet A and DWP14012 tablet B in people with Healthy, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
This is a randomized, open-label, single dose study to evaluate the safety and pharmacokinetics of DWP14012 tablet A and DWP14012 tablet B in healthy volunteers Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- 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
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2019to Jan 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult aged between 19 and 45 at screening
- Those whose weight is 55 kg and more and BMI is between 17.5 and 30.5 kg/m2
- Subjects who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc
Who cannot join
- Subjects who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
- Subjects 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 ppendectomy and herniotomy)
- Subjects who showed positive result for Helicobacter pylori test
- Subjects with serum AST (SGOT) or ALT (SGPT) level >1.5 times the upper limit of the normal range at the time of the screening examination
- Subjects with a history of drug abuse or a positive urine screening for drug abuse
- 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
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
Kim, 82-63-259-3480, irb@cuh.co.kr
About this study
Official title: A Randomized, Open-label, Single Dose Study to Evaluate the Safety and Pharmacokinetics of DWP14012 Tablet A and DWP14012 Tablet B in Healthy Volunteers
This is a randomized, open-label, single dose study to evaluate the safety and pharmacokinetics of DWP14012 tablet A and DWP14012 tablet B in healthy volunteers
- Conditions
- Healthy
- 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
Period 1: DWP14012 tablet B Period 2: DWP14012 tablet A
DWP14012 tablet BDrug
Period 1: DWP14012 tablet A Period 2: DWP14012 tablet B
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 (Tablet B - Tablet A) | Experimental | Period 1 : DWP14012 tablet B Period 2: DWP14012 tablet A Receives: Drug: DWP14012 tablet A; Drug: DWP14012 tablet B |
| Sequence 2 (Tablet A - Tablet B) | Experimental | Period 1 : DWP14012 tablet A Period 2: DWP14012 tablet B 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.
AUCt: Area under the drug concentration-time curve from time 0 to tau (dosing interval)
each period
Measured: 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour
Cmax: Peak concentration of DWP14012
each period
Measured: 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour
Secondary outcomes (5)
AUCinf: Area under the drug concentration-time curve from time 0 to infinity
each period
Measured: 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour
Tmax: Time of maximum concentration
each period
Measured: 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour
t1/2: Terminal elimination half-life
each period
Measured: 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour
CL/F: Apperent Clearance
each period
Measured: 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour
Vd/F: Apparent volume of distribution
each period
Measured: 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study startNov 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 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
- NCT04167267
- Sponsor's protocol ID
- DW_DWP14012102
- Status last verified
- Nov 2019
- First submitted
- 15 Nov 2019
- Last updated
- 22 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose Study to Evaluate the Safety and Pharmacokinetics of DWP14012 Tablet A and DWP14012 Tablet B in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04167267
- Acronym / sponsor ID
- DW_DWP14012102
- Conditions
- Healthy
- 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
- Nov 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 18 Nov 2019 (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.
This is a randomized, open-label, single dose study to evaluate the safety and pharmacokinetics of DWP14012 tablet A and DWP14012 tablet B in healthy volunteers
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 (Tablet B - Tablet A) | Experimental | Drug: DWP14012 tablet A, Drug: DWP14012 tablet BPeriod 1 : DWP14012 tablet B Period 2: DWP14012 tablet A |
| Sequence 2 (Tablet A - Tablet B) | Experimental | Drug: DWP14012 tablet A, Drug: DWP14012 tablet BPeriod 1 : DWP14012 tablet A Period 2: DWP14012 tablet B |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult aged between 19 and 45 at screening
- Those whose weight is 55 kg and more and BMI is between 17.5 and 30.5 kg/m2
- Subjects who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc
Key exclusion criteria (7 listed)
- Subjects who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
- Subjects 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 ppendectomy and herniotomy)
- Subjects who showed positive result for Helicobacter pylori test
- Subjects with serum AST (SGOT) or ALT (SGPT) level >1.5 times the upper limit of the normal range at the time of the screening examination
- Subjects with a history of drug abuse or a positive urine screening for drug abuse
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 APeriod 1: DWP14012 tablet B Period 2: DWP14012 tablet A | Drug | Sequence 1 (Tablet B - Tablet A), Sequence 2 (Tablet A - Tablet B) |
| DWP14012 tablet BPeriod 1: DWP14012 tablet A Period 2: DWP14012 tablet B | Drug | Sequence 1 (Tablet B - Tablet A), Sequence 2 (Tablet A - Tablet B) |
Primary outcome
AUCt: Area under the drug concentration-time curve from time 0 to tau (dosing interval)
Time frame: 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour
each period
Cmax: Peak concentration of DWP14012
Time frame: 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour
each period
5 secondary outcomes
AUCinf: Area under the drug concentration-time curve from time 0 to infinity
Time frame: 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour
Tmax: Time of maximum concentration
Time frame: 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour
t1/2: Terminal elimination half-life
Time frame: 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour
CL/F: Apperent Clearance
Time frame: 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour
Vd/F: Apparent volume of distribution
Time frame: 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- 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.
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 Healthy, 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 3 inclusion and 7 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 22 Nov 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCt: Area under the drug concentration-time curve from time 0 to tau (dosing interval) (time frame: 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour). 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 22 Nov 2019.