GERDPhase 1NCT04830930
A Study to Investigate the Effect of Food on the PK, PD of CKD-381 in Healthy Volunteers
A Phase 1 study testing CKD-381 in people with GERD, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
A study to investigate the effect of food on the Pharmacokinetics and pharmacodynamics of CKD-381 in healthy volunteers Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- GERD
- What is being tested?
- CKD-381
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Apr 2021to 26 Jul 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 19 aged and 50 aged in healthy adult
- Body weight more than 55.0kg and body mass index over 18.0kg/m2 and under 30.0kg/m2
- Have negative result on Helicobacter Pylori antibody test
Who cannot join
- Have clinically significant disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system or mental illness, or a history of mental disease.
- Have a gastrointestinal disease history(including surgery) that can effect evaluation of safety, pharmacokinetics and pharmacodynamics of investigational product.
- Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of investigational product, additives or benzimidazole family.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Jongno-gu, 03080
About this study
Official title: A Randomized, Open-label, Single-dose, Crossover Study to Investigate the Effect of Food on the Pharmacokinetics and Pharmacodynamics of CKD-381 in Healthy Volunteers
A study to investigate the effect of food on the Pharmacokinetics and pharmacodynamics of CKD-381 in healthy volunteers
Read the detailed description
A randomized, open-label, single-dose, crossover study to investigate the effect of food on the pharmacokinetics and pharmacodynamics of CKD-381 in healthy volunteers
- Conditions
- GERD
- Being tested
- CKD-381
- Keywords
- CKD-381
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-381Drug
single-dose, oral administration of CKD-381 1 tablet
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Period 1: fasted condition/ Period 2: fed condition Receives: Drug: CKD-381 |
| Sequence 2 | Experimental | Period 1: fed condition/ Period 2: fasted condition Receives: Drug: CKD-381 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
maximum observed concentration after dose
Measured: 0-24 hours
AUClast
Area under the plasma concentration versus time curve over the dosing interval after dose
Measured: 0-24 hours
Percent decrease from baseline in integrated gastric acidity for 24-hour interval after dose
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start21 Apr 2021
- Primary completion17 Jun 2021
- Study completion26 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe 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
- Model description
- Crossover Assignment
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyungsang Yu, M.D., Ph.D., Principal investigator, ksyu@snu.ac.kr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830930
- Sponsor's protocol ID
- A73_04FDI2102
- Status last verified
- Mar 2021
- First submitted
- 1 Apr 2021
- Last updated
- 18 Aug 2021
- 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 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, Crossover Study to Investigate the Effect of Food on the Pharmacokinetics and Pharmacodynamics of CKD-381 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04830930
- Acronym / sponsor ID
- A73_04FDI2102
- Conditions
- GERD
- Keywords
- CKD-381
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 17 Jun 2021 (actual)
- Study completion
- 26 Jul 2021 (actual)
- First posted
- 5 Apr 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.
A study to investigate the effect of food on the Pharmacokinetics and pharmacodynamics of CKD-381 in healthy volunteers
Detailed description
A randomized, open-label, single-dose, crossover study to investigate the effect of food on the pharmacokinetics and pharmacodynamics of CKD-381 in healthy volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Crossover Assignment
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: CKD-381Period 1: fasted condition/ Period 2: fed condition |
| Sequence 2 | Experimental | Drug: CKD-381Period 1: fed condition/ Period 2: fasted condition |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Between 19 aged and 50 aged in healthy adult
- Body weight more than 55.0kg and body mass index over 18.0kg/m2 and under 30.0kg/m2
- Have negative result on Helicobacter Pylori antibody test
Key exclusion criteria (3 listed)
- Have clinically significant disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system or mental illness, or a history of mental disease.
- Have a gastrointestinal disease history(including surgery) that can effect evaluation of safety, pharmacokinetics and pharmacodynamics of investigational product.
- Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of investigational product, additives or benzimidazole family.
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 |
|---|---|---|
| CKD-381single-dose, oral administration of CKD-381 1 tablet | Drug | Sequence 1, Sequence 2 |
Primary outcome
Cmax
Time frame: 0-24 hours
maximum observed concentration after dose
AUClast
Time frame: 0-24 hours
Area under the plasma concentration versus time curve over the dosing interval after dose
Percent decrease from baseline in integrated gastric acidity for 24-hour interval after dose
Time frame: 0-24 hours
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 18 Aug 2021.
- 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.
Kyungsang Yu, M.D., Ph.D. principal investigator
ksyu@snu.ac.kr
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 CKD-381 in people with GERD, run by Chong Kun Dang Pharmaceutical 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 3 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 18 Aug 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?
Cmax (time frame: 0-24 hours). 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 18 Aug 2021.