GERDPhase 1NCT05108038
A Study to Evaluate the PK, PD and Safety of CKD-382 in Healthy Subjects
A Phase 1 study testing CKD-382, D860, D027 in people with GERD, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
to evaluate the pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382, D860 and D027 in healthy subjects 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-382, D860, D027
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Oct 2021to Feb 2022
- 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 50kg
- BMI more than 18.0 and under 27.0
- Who has 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 drug absorption
- Hypersensitivity reaction of clinically significant hypersensitivity reaction in the history of Esomeprazole, additives or benzimidazole family
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Chungbuk Ntional University Hospital
Cheongju-si
Minkyu Park, Ph.D, 043-269-8708, mk_park@chnuhctc.com
About this study
Official title: A Randomized, Open-label, Crossover Phase 1 Clinical Trial to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety After Single/Multiple Administration of CKD-382, D860 and D027 in Healthy Subjects
to evaluate the pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382, D860 and D027 in healthy subjects
Read the detailed description
A randomized, open-label, crossover phase 1 clinical trial to evaluate the pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382, D860 and D027 in healthy subjects
- Conditions
- GERD
- Being tested
- CKD-382, D860, D027
- Keywords
- CKD-382, D860, D027
- 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-382, D860, D027Drug
QD, PO for 7days
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Period 1: CKD-382 Period 2: D860 Period 3: D027 Receives: Drug: CKD-382, D860, D027 |
| B | Experimental | Period 1: CKD-382 Period 2: D027 Period 3: D860 Receives: Drug: CKD-382, D860, D027 |
| C | Experimental | Period 1: D860 Period 2: D027 Period 3: CKD-382 Receives: Drug: CKD-382, D860, D027 |
| D | Experimental | Period 1: D860 Period 2: CKD-382 Period 3: D027 Receives: Drug: CKD-382, D860, D027 |
| E | Experimental | Period 1: D027 Period 2: D860 Period 3: CKD-382 Receives: Drug: CKD-382, D860, D027 |
| F | Experimental | Period 1: D027 Period 2: CKD-382 Period 3: D860 Receives: Drug: CKD-382, D860, D027 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Pharmacokinetic Endpoint
AUCt,ss Evaluation after multiple dose
-AUCt,ss: Area under the plasma drug concentration-time curve within a dosing interval in steady-state
Measured: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
Primary Pharmacodynamic Endpoint
Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose
Measured: 24 hours after multiple dose for 7 days compared to baseline
Secondary outcomes (15)
(1) Secondary Pharmacokinetic Endpoint
Cmax,ss Evaluation after multiple dose
-Cmax,ss: Maximum concentration of drug in plasma
Measured: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(1) Secondary Pharmacokinetic Endpoint
Tmax,ss Evaluation after multiple dose
-Tmax,ss: Time to maximum plasma concentration
Measured: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(1) Secondary Pharmacokinetic Endpoint
t1/2ss Evaluation after multiple dose
-t1/ss: Terminal elimination half life in steady state
Measured: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(1) Secondary Pharmacokinetic Endpoint
CLss/F Evaluation after multiple dose
-CLss/F: Apparent Clearance in steady-state
Measured: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(1) Secondary Pharmacokinetic Endpoint
Vzss/F Evaluation after multiple dose
-Vzss/F: Apparent Volume of Distribution at steady state
Measured: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(1) Secondary Pharmacokinetic Endpoint
R Evaluation after multiple dose
-R: Accumulation ratio
Measured: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(1) Secondary Pharmacokinetic Endpoint
PTF Evaluation after multiple dose
-PTF: Peak to Trough Fluctuation
Measured: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(2) Secondary Pharmacokinetic Endpoint
Cmax Evaluation after single dose
-Cmax: Maximum concentration of drug in plasma
Measured: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(2) Secondary Pharmacokinetic Endpoint
AUC0-t Evaluation after single dose
-AUC0-t: Area under the plasma concentration-time curve from the point of administration to last time point of blood sampling
Measured: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(2) Secondary Pharmacokinetic Endpoint
Tmax Evaluation after single dose
-Tmax: Time to maximum plasma concentration
Measured: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(2) Secondary Pharmacokinetic Endpoint
t1/2 Evaluation after single dose
-t1/2: Terminal elimination half-life
Measured: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(2) Secondary Pharmacokinetic Endpoint
CL/F Evaluation after single dose
-CL/F: Apparent Clearance
Measured: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(2) Secondary Pharmacokinetic Endpoint
Vz/F Evaluation after single dose
-Vz/F: Apparent Volume of Distribution
Measured: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(1) Secondary Pharmacodynamic Endpoint
Percent decrease from baseline in integrated gastric acidity for 24-hour interval after first dose
Measured: 24 hours after first dose compared to baseline
(2) Secondary Pharmacodynamic Endpoint
Percent of time with gastric pH≤4 for 24-hour interval after first or 7th dose
Measured: 24 hours after first dose and multiple dose for 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start7 Oct 2021
- Primary completionFeb 2022 (estimated)
- Study completionFeb 2022 (estimated)
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
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108038
- Sponsor's protocol ID
- A105_02PK2115
- Status last verified
- Oct 2021
- First submitted
- 14 Oct 2021
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- 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 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Crossover Phase 1 Clinical Trial to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety After Single/Multiple Administration of CKD-382, D860 and D027 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05108038
- Acronym / sponsor ID
- A105_02PK2115
- Conditions
- GERD
- Keywords
- CKD-382, D860, D027
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 4 Nov 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.
to evaluate the pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382, D860 and D027 in healthy subjects
Detailed description
A randomized, open-label, crossover phase 1 clinical trial to evaluate the pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382, D860 and D027 in healthy subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: CKD-382, D860, D027Period 1: CKD-382 Period 2: D860 Period 3: D027 |
| B | Experimental | Drug: CKD-382, D860, D027Period 1: CKD-382 Period 2: D027 Period 3: D860 |
| C | Experimental | Drug: CKD-382, D860, D027Period 1: D860 Period 2: D027 Period 3: CKD-382 |
| D | Experimental | Drug: CKD-382, D860, D027Period 1: D860 Period 2: CKD-382 Period 3: D027 |
| E | Experimental | Drug: CKD-382, D860, D027Period 1: D027 Period 2: D860 Period 3: CKD-382 |
| F | Experimental | Drug: CKD-382, D860, D027Period 1: D027 Period 2: CKD-382 Period 3: D860 |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between 19 aged and 50 aged in healthy adult
- Body weight more than 50kg
- BMI more than 18.0 and under 27.0
- Who has 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 drug absorption
- Hypersensitivity reaction of clinically significant hypersensitivity reaction in the history of Esomeprazole, 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-382, D860, D027QD, PO for 7days | Drug | A, B, C, D, E, F |
Primary outcome
Primary Pharmacokinetic Endpoint
Time frame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
AUCt,ss Evaluation after multiple dose -AUCt,ss: Area under the plasma drug concentration-time curve within a dosing interval in steady-state
Primary Pharmacodynamic Endpoint
Time frame: 24 hours after multiple dose for 7 days compared to baseline
Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose
15 secondary outcomes
(1) Secondary Pharmacokinetic Endpoint
Time frame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(1) Secondary Pharmacokinetic Endpoint
Time frame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(1) Secondary Pharmacokinetic Endpoint
Time frame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(1) Secondary Pharmacokinetic Endpoint
Time frame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(1) Secondary Pharmacokinetic Endpoint
Time frame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(1) Secondary Pharmacokinetic Endpoint
Time frame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(1) Secondary Pharmacokinetic Endpoint
Time frame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(2) Secondary Pharmacokinetic Endpoint
Time frame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(2) Secondary Pharmacokinetic Endpoint
Time frame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(2) Secondary Pharmacokinetic Endpoint
Time frame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(2) Secondary Pharmacokinetic Endpoint
Time frame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(2) Secondary Pharmacokinetic Endpoint
Time frame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(2) Secondary Pharmacokinetic Endpoint
Time frame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
(1) Secondary Pharmacodynamic Endpoint
Time frame: 24 hours after first dose compared to baseline
(2) Secondary Pharmacodynamic Endpoint
Time frame: 24 hours after first dose and multiple dose for 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 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.
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-382, D860, D027 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 4 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: status not confirmed, as of the sponsor's last update on 4 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minkyu Park, Ph.D (043-269-8708, mk_park@cbnuhctc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Pharmacokinetic Endpoint (time frame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours). 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 4 Nov 2021.