Erosive Gastroesophageal Reflux DiseasePhase 1NCT06437951
to Evaluate the Safety/Tolerability and Pharmacokinetics, and Pharmacodynamics of DWP14012 Injection
A Phase 1 study testing Fexuprazan Injection, Fexuprazan Injection_part 2 and Fexuprazan Injection_part 3 in people with Erosive Gastroesophageal Reflux Disease, run by Daewoong Pharmaceutical Co. LTD..
Trial summary
to evaluate the safety/tolerability and pharmacokinetics, and pharmacodynamics after intravenous DWP14012 injection in healthy participants Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Erosive Gastroesophageal Reflux Disease
- What is being tested?
- Fexuprazan Injection, Fexuprazan Injection_part 2 and Fexuprazan Injection_part 3
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to May 2025
- 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 volunteers aged 19 to 50 at the time of screening tests
- Those who weigh more than 50.0 kg, 90.0 kg or less, and have a BMI of 18.5 or more and 29.9 or less at the time of screening inspection BMI (kg/m2) = Weight (kg) / {Height (m)}2
- In the case of female volunteers, those who are not necessarily pregnant or lactating or who are in surgical infertility (bilateral ovarian obstruction, hysterectomy, bilateral ovarian resection, etc.)
- A person who voluntarily decides to participate after hearing and fully understanding the detailed explanation of this clinical trial and agrees in writing before a screening procedure
- A person who is suitable for this test when judging the tester by physical examination, clinical laboratory examination, questionnaire, etc
Who cannot join
- Clinically significant hepatomegaly (severe liver disorder, viral hepatitis, etc.), kidney (severe renal disorder, etc.), nervous system, immune system, respiratory system, digestive system, endocrine system, blood and tumor, cardiovascular system (heart failure, Torsades de points, etc.), urinary system, mental system (fever disorder, obsessive compulsive disorder, etc.), sexual dysfunction, etc
- A person who has a history of gastrointestinal diseases (such as Crohn's disease, ulcers, gastritis, gastritis, gastroesophageal reflux disease, etc.) or surgery (except simple appendectomy or hernia) that may affect the safety, pharmacokinetics and pharmacodynamic evaluation of clinical medicines
- Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- A person who has been tested positive for Helicobacter pylori
- Those who have anatomical impairments in insertion and maintenance of the pH meter catheter etc
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single/Multiple-dose, Phase 1 Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetics, and Pharmacodynamics After Intravenous DWP14012 Injection in Healthy Participants
to evaluate the safety/tolerability and pharmacokinetics, and pharmacodynamics after intravenous DWP14012 injection in healthy participants
- Conditions
- Erosive Gastroesophageal Reflux Disease
- Being tested
- Fexuprazan Injection, Fexuprazan Injection placebo, Fexuprazan Injection_part 2, Fexuprazan Injection_part 3, Fexuprazan tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fexuprazan InjectionDrug
20/40/80 mg
Fexuprazan Injection placeboDrug
20/40/80 mg
Fexuprazan Injection_part 2Drug
20mg
Fexuprazan Injection_part 3Drug
40mg
Fexuprazan tabletDrug
40mg
| Study group | Role | What they receive |
|---|---|---|
| Part1_test group | Experimental | IV injection of test drugs by dose group Receives: Drug: Fexuprazan Injection |
| Part1_placebo group | Placebo comparator | IV injection of test drugs by dose group Receives: Drug: Fexuprazan Injection placebo |
| Part2 | Experimental | All Participants take IV injection of test drugs Receives: Drug: Fexuprazan Injection_part 2 |
| Part3_test group | Experimental | In the case of test group, take IV injection in the period 1 and take a tablet in the period 2 Receives: Drug: Fexuprazan Injection_part 3; Drug: Fexuprazan tablet |
| Part3_reference group | Active comparator | In the case of reference group, take a tablet in the period 1 and take IV injection in the period 2 Receives: Drug: Fexuprazan Injection_part 3; Drug: Fexuprazan tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK of Fexuprazan
- Blood and urinary concentrations of Fexuprazan by part
Measured: 0 and 72hour
PK of metabolite
- Blood and urinary concentrations of metabolite by part
Measured: 0 and 72hour
PD of Fexuprazan
pH monitoring
Measured: up to 15days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study startJul 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erosive Gastroesophageal Reflux DiseaseStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Injin zhang, Ph.D, Principal investigator, Seoul National University College of Medicine and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437951
- Sponsor's protocol ID
- DW_DWJ1521104
- Status last verified
- May 2024
- First submitted
- 13 May 2024
- Last updated
- 3 Jun 2024
- 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 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single/Multiple-dose, Phase 1 Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetics, and Pharmacodynamics After Intravenous DWP14012 Injection in Healthy Participants
- ClinicalTrials.gov ID
- NCT06437951
- Acronym / sponsor ID
- DW_DWJ1521104
- Conditions
- Erosive Gastroesophageal Reflux Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 31 May 2024 (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/tolerability and pharmacokinetics, and pharmacodynamics after intravenous DWP14012 injection in healthy participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part1_test group | Experimental | Drug: Fexuprazan InjectionIV injection of test drugs by dose group |
| Part1_placebo group | Placebo comparator | Drug: Fexuprazan Injection placeboIV injection of test drugs by dose group |
| Part2 | Experimental | Drug: Fexuprazan Injection_part 2All Participants take IV injection of test drugs |
| Part3_test group | Experimental | Drug: Fexuprazan Injection_part 3, Drug: Fexuprazan tabletIn the case of test group, take IV injection in the period 1 and take a tablet in the period 2 |
| Part3_reference group | Active comparator | Drug: Fexuprazan Injection_part 3, Drug: Fexuprazan tabletIn the case of reference group, take a tablet in the period 1 and take IV injection in the period 2 |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult volunteers aged 19 to 50 at the time of screening tests
- Those who weigh more than 50.0 kg, 90.0 kg or less, and have a BMI of 18.5 or more and 29.9 or less at the time of screening inspection BMI (kg/m2) = Weight (kg) / {Height (m)}2
- In the case of female volunteers, those who are not necessarily pregnant or lactating or who are in surgical infertility (bilateral ovarian obstruction, hysterectomy, bilateral ovarian resection, etc.)
- A person who voluntarily decides to participate after hearing and fully understanding the detailed explanation of this clinical trial and agrees in writing before a screening procedure
- A person who is suitable for this test when judging the tester by physical examination, clinical laboratory examination, questionnaire, etc
Key exclusion criteria (5 listed)
- Clinically significant hepatomegaly (severe liver disorder, viral hepatitis, etc.), kidney (severe renal disorder, etc.), nervous system, immune system, respiratory system, digestive system, endocrine system, blood and tumor, cardiovascular system (heart failure, Torsades de points, etc.), urinary system, mental system (fever disorder, obsessive compulsive disorder, etc.), sexual dysfunction, etc
- A person who has a history of gastrointestinal diseases (such as Crohn's disease, ulcers, gastritis, gastritis, gastroesophageal reflux disease, etc.) or surgery (except simple appendectomy or hernia) that may affect the safety, pharmacokinetics and pharmacodynamic evaluation of clinical medicines
- Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- A person who has been tested positive for Helicobacter pylori
- Those who have anatomical impairments in insertion and maintenance of the pH meter catheter etc
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 |
|---|---|---|
| Fexuprazan Injection20/40/80 mg | Drug | Part1_test group |
| Fexuprazan Injection placebo20/40/80 mg | Drug | Part1_placebo group |
| Fexuprazan Injection_part 220mg | Drug | Part2 |
| Fexuprazan Injection_part 340mg | Drug | Part3_reference group, Part3_test group |
| Fexuprazan tablet40mg | Drug | Part3_reference group, Part3_test group |
Primary outcome
PK of Fexuprazan
Time frame: 0 and 72hour
1. Blood and urinary concentrations of Fexuprazan by part
PK of metabolite
Time frame: 0 and 72hour
1. Blood and urinary concentrations of metabolite by part
PD of Fexuprazan
Time frame: up to 15days
pH monitoring
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
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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.
Injin zhang, Ph.D principal investigator
Seoul National University College of Medicine and Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fexuprazan Injection, Fexuprazan Injection_part 2 and Fexuprazan Injection_part 3 in people with Erosive Gastroesophageal Reflux Disease, run by Daewoong Pharmaceutical Co. LTD..
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 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 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sujong Lee, Ph.D (027408910, leesj0323@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK of Fexuprazan (time frame: 0 and 72hour). The study lists 3 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 3 Jun 2024.