Erosive EsophagitisPhase 1NCT02995239
A Study to Compare the Pharmacokinetic Characteristics of CJ-12420
A Phase 1 study testing CJ-12420 formulation 2 and CJ-12420 formulation 1 in people with Erosive Esophagitis, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
To compare the pharmacokinetics after administration of different formulation of CJ-12420 Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erosive Esophagitis
- What is being tested?
- CJ-12420 formulation 2 and CJ-12420 formulation 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2015to Apr 2015
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male aged 19 to 45 years at the screening
- Subject who is over 50kg with BMI between 19 kg/m2 to 28 kg/m2 (inclusive)
- Subject who fully understood after being informed detailed description of clinical trial, written informed consent voluntarily to observe the precautions.
Who cannot join
- Subject who fall under the criteria below in laboratory test.
- AST, ALT, ALP, GGT, total bilirubin, BUN, creatinine > UNL x 1.5
- Subject who with low blood pressure with clinical significance at screening test.
- (systolic blood pressure is less than 90 mmHg or over 140 mmHg, and diastolic blood pressure is less than 50 mmHg or over 90 mmHg)
- Subject who has a medical history of symptomatic GERD, erosive esophagitis or duodenal ulcer, gastric ulcer, barrett's esophagus or zollinger-ellison syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single Dose, Crossover Study to Compare the Pharmacokinetic Characteristics of CJ-12420 in Healthy Male Volunteers
To compare the pharmacokinetics after administration of different formulation of CJ-12420
Read the detailed description
The purpose of this study is to compare the pharmacokinetics after a single dose administration of CJ-12420 formulation 1 and formulation 2.
- Conditions
- Erosive Esophagitis
- Being tested
- CJ-12420 formulation 2, CJ-12420 formulation 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CJ-12420 formulation 2Drug
CJ-12420 formulation 2
CJ-12420 formulation 1Drug
CJ-12420 formulation 1
| Study group | Role | What they receive |
|---|---|---|
| CJ-12420 formulation 1 | Active comparator | CJ-12420 formulation 1 Receives: Drug: CJ-12420 formulation 2 |
| CJ-12420 formulation 2 | Active comparator | CJ-12420 formulation 2 Receives: Drug: CJ-12420 formulation 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the AUClast
Measured: Up to 48 hours
Secondary outcomes (4)
Assessment of the AUCinf
Measured: Up to 48 hours
Tmax
Measured: Up to 48 hours
t1/2
Measured: Up to 48 hours
Vd/F
Measured: Up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startApr 2015
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erosive EsophagitisStudies of the same condition, open and under way.
- More trials run by HK inno.N CorporationThe 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min-Gul Kim, MD, Principal investigator, Chonbuk university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995239
- Sponsor's protocol ID
- CJ_APA_106
- Status last verified
- Dec 2016
- First submitted
- 15 Jul 2016
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, Crossover Study to Compare the Pharmacokinetic Characteristics of CJ-12420 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02995239
- Acronym / sponsor ID
- CJ_APA_106
- Conditions
- Erosive Esophagitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 16 Dec 2016 (estimated)
- 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 compare the pharmacokinetics after administration of different formulation of CJ-12420
Detailed description
The purpose of this study is to compare the pharmacokinetics after a single dose administration of CJ-12420 formulation 1 and formulation 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CJ-12420 formulation 1 | Active comparator | Drug: CJ-12420 formulation 2CJ-12420 formulation 1 |
| CJ-12420 formulation 2 | Active comparator | Drug: CJ-12420 formulation 1CJ-12420 formulation 2 |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male aged 19 to 45 years at the screening
- Subject who is over 50kg with BMI between 19 kg/m2 to 28 kg/m2 (inclusive)
- Subject who fully understood after being informed detailed description of clinical trial, written informed consent voluntarily to observe the precautions.
Key exclusion criteria (5 listed)
- Subject who fall under the criteria below in laboratory test.
- Subject who with low blood pressure with clinical significance at screening test.
- Subject who has a medical history of symptomatic GERD, erosive esophagitis or duodenal ulcer, gastric ulcer, barrett's esophagus or zollinger-ellison syndrome.
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 |
|---|---|---|
| CJ-12420 formulation 2CJ-12420 formulation 2 | Drug | CJ-12420 formulation 1 |
| CJ-12420 formulation 1CJ-12420 formulation 1 | Drug | CJ-12420 formulation 2 |
Primary outcome
Assessment of the AUClast
Time frame: Up to 48 hours
4 secondary outcomes
Assessment of the AUCinf
Time frame: Up to 48 hours
Tmax
Time frame: Up to 48 hours
t1/2
Time frame: Up to 48 hours
Vd/F
Time frame: Up to 48 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 16 Dec 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Erosive Esophagitis
RecruitingObservational study
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Erosive Esophagitis, Heartburn
Recruiting
Neuroregulators for the Treatment of Diseases Associated With Esophageal-brain-gut Axis Communication Abnormalities.
Gut-Brain Disorders, GERD Without Erosive Esophagitis
Recruiting
Cognitive-behavioral Therapy for the Diseases Associated With Esophageal-brain-gut Axis Communication Abnormalities.
Gut-Brain Disorders, GERD Without Erosive Esophagitis
Not yet recruitingPhase 3
Efficacy and Safety of DWP14012 for Long-Term Maintenance Therapy in Patients With Healed Erosive Esophagitis
Healed Erosive Esophagitis
Recruiting
Real-life Study of Changes of Gastroesophageal Reflux Disease Manifestations Due to Behavioural and Diet Adherence
Gastroesophageal Reflux Disease, GERD
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.
Min-Gul Kim, MD principal investigator
Chonbuk university hospital
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 CJ-12420 formulation 2 and CJ-12420 formulation 1 in people with Erosive Esophagitis, run by HK inno.N Corporation 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 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: finished, as of the sponsor's last update on 16 Dec 2016. 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?
Assessment of the AUClast (time frame: Up to 48 hours). 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 16 Dec 2016; AzTrials last refreshed its copy on 8 Nov 2026.