Gastroesophagus Reflux DiseasePhase 1NCT04690868
A Study to Compare PK, PD and Safety of the AD-213-A and AD-2131
A Phase 1 study testing AD-213-A and AD-2131 in people with Gastroesophagus Reflux Disease, run by Addpharma Inc. at 1 site in South Korea.
Trial summary
A study to compare safety, pharmacokinetics and pharmacodynamics of AD-213-A to AD-2131 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastroesophagus Reflux Disease
- What is being tested?
- AD-213-A and AD-2131
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Oct 2021to 21 Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults over 19 years of age.
- Weight is more than 50kg and BMI is more than 18.0 kg/m^2 , no more than 27.0 kg/m^2.
- Subject who has been judged to be eligible for clinical laboratory tests and electrocardiogram tests such as serum tests, hematology tests, blood chemistry tests, and urinary tests conducted within four weeks prior to the administration of clinical trials.
- Subjects who has heard and fully understood the detailed description of this clinical trial and have willingness to sign of informed consent in writing.
Who cannot join
- A subject who has a history that can affect the absorption, distribution, metabolism, or excretion of a drug.
- As a result of laboratory tests, the following figures: ALT or AST or total bilirubin > 1.5 times upper limit of normal range.
- As a result of laboratory tests, the following figures: Creatinine clearance < 80mL/min.
- Subjects who judged ineligible by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Multi Dose, Cross Over Design Clinical Study to Evaluate the Pharmacokinetic Pharmacodynamic Characteristics and Safety of AD-213-A and AD-2131 After Oral Administration in Healthy Adult Subjects
A study to compare safety, pharmacokinetics and pharmacodynamics of AD-213-A to AD-2131 in healthy volunteers.
- Conditions
- Gastroesophagus Reflux Disease
- Being tested
- AD-213-A, AD-2131
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD-213-ADrug
1 tablet administered before the breakfast during 5 days
AD-2131Drug
1 tablet administered before the breakfast during 5 days
| Study group | Role | What they receive |
|---|---|---|
| ARM 1 | Experimental | Period 1 : Reference Drug(AD-2131) Period 2 : Test Drug(AD-213-A) Receives: Drug: AD-213-A; Drug: AD-2131 |
| ARM 2 | Experimental | Period 1 : Test Drug(AD-213-A) Period 2 : Reference Drug(AD-2131) Receives: Drug: AD-213-A; Drug: AD-2131 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCtau
Evaluation PK after multiple dose
Measured: From Day 1 up to Day 17
Integrated gastric acidity(%Decrease form baseline)
Evaluation PD after multiple dose
Measured: 4 times from Day -1 to Day 17
Secondary outcomes (16)
Cmax
Evaluation PK after single dose
Measured: Day 1
AUClast
Evaluation PK after single dose
Measured: Day 1
AUCinf
Evaluation PK after single dose
Measured: Day 1
Tmax
Evaluation PK after single dose
Measured: Day 1
t1/2
Evaluation PK after single dose
Measured: Day 1
CL/F
Evaluation PK after single dose
Measured: Day 1
Vd/F
Evaluation PK after single dose
Measured: Day 1
Cmax,ss
Evaluation PK after multiple dose
Measured: From Day 1 up to Day 17
Cmin,ss
Evaluation PK after multiple dose
Measured: From Day 1 up to Day 17
AUCinf
Evaluation PK after multiple dose
Measured: From Day 1 up to Day 17
Tmax,ss
Evaluation PK after multiple dose
Measured: From Day 1 up to Day 17
t1/2
Evaluation PK after multiple dose
Measured: From Day 1 up to Day 17
CLss/F
Evaluation PK after multiple dose
Measured: From Day 1 up to Day 17
Vdss/F
Evaluation PK after multiple dose
Measured: From Day 1 up to Day 17
Integrated gastric acidity(Variations form baseline)
Evaluation PD after multiple dose
Measured: 4 times from Day -1 to Day 17
Percentage of time to maintain gastric pH 4.0 or higher
Evaluation PD after multiple dose
Measured: 4 times from Day -1 to Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start15 Oct 2021
- Primary completion11 Dec 2021
- Study completion21 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophagus Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Addpharma Inc.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
- Crossover
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Addpharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690868
- Sponsor's protocol ID
- AD-213PK/PD
- Status last verified
- Nov 2021
- First submitted
- 22 Dec 2020
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Multi Dose, Cross Over Design Clinical Study to Evaluate the Pharmacokinetic Pharmacodynamic Characteristics and Safety of AD-213-A and AD-2131 After Oral Administration in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04690868
- Acronym / sponsor ID
- AD-213PK/PD
- Conditions
- Gastroesophagus Reflux Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Addpharma Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 11 Dec 2021 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 31 Dec 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.
A study to compare safety, pharmacokinetics and pharmacodynamics of AD-213-A to AD-2131 in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM 1 | Experimental | Drug: AD-213-A, Drug: AD-2131Period 1 : Reference Drug(AD-2131) Period 2 : Test Drug(AD-213-A) |
| ARM 2 | Experimental | Drug: AD-213-A, Drug: AD-2131Period 1 : Test Drug(AD-213-A) Period 2 : Reference Drug(AD-2131) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy adults over 19 years of age.
- Weight is more than 50kg and BMI is more than 18.0 kg/m^2 , no more than 27.0 kg/m^2.
- Subject who has been judged to be eligible for clinical laboratory tests and electrocardiogram tests such as serum tests, hematology tests, blood chemistry tests, and urinary tests conducted within four weeks prior to the administration of clinical trials.
- Subjects who has heard and fully understood the detailed description of this clinical trial and have willingness to sign of informed consent in writing.
Key exclusion criteria (4 listed)
- A subject who has a history that can affect the absorption, distribution, metabolism, or excretion of a drug.
- As a result of laboratory tests, the following figures: ALT or AST or total bilirubin > 1.5 times upper limit of normal range.
- As a result of laboratory tests, the following figures: Creatinine clearance < 80mL/min.
- Subjects who judged ineligible by the investigator.
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 |
|---|---|---|
| AD-213-A1 tablet administered before the breakfast during 5 days | Drug | ARM 1, ARM 2 |
| AD-21311 tablet administered before the breakfast during 5 days | Drug | ARM 1, ARM 2 |
Primary outcome
AUCtau
Time frame: From Day 1 up to Day 17
Evaluation PK after multiple dose
Integrated gastric acidity(%Decrease form baseline)
Time frame: 4 times from Day -1 to Day 17
Evaluation PD after multiple dose
16 secondary outcomes
Cmax
Time frame: Day 1
AUClast
Time frame: Day 1
AUCinf
Time frame: Day 1
Tmax
Time frame: Day 1
t1/2
Time frame: Day 1
CL/F
Time frame: Day 1
Vd/F
Time frame: Day 1
Cmax,ss
Time frame: From Day 1 up to Day 17
Cmin,ss
Time frame: From Day 1 up to Day 17
AUCinf
Time frame: From Day 1 up to Day 17
Tmax,ss
Time frame: From Day 1 up to Day 17
t1/2
Time frame: From Day 1 up to Day 17
CLss/F
Time frame: From Day 1 up to Day 17
Vdss/F
Time frame: From Day 1 up to Day 17
Integrated gastric acidity(Variations form baseline)
Time frame: 4 times from Day -1 to Day 17
Percentage of time to maintain gastric pH 4.0 or higher
Time frame: 4 times from Day -1 to Day 17
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 Apr 2022.
- Individual participant dataSharing planned: No
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 AD-213-A and AD-2131 in people with Gastroesophagus Reflux Disease, run by Addpharma Inc. 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 4 inclusion and 4 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 Apr 2022. 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?
AUCtau (time frame: From Day 1 up to Day 17). 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 27 Apr 2022.