HealthyPhase 1NCT03009760
To Investigate Pharmacokinetics and Pharmacodynamics of CJ-12420 After Single and Multiple Dose Administration
A Phase 1 study testing CJ-12420 50mg(HP-), CJ-12420 100mg(HP-) and CJ-12420 50mg(HP+) in people with Healthy, run by HK inno.N Corporation.
Trial summary
The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of CJ-12420 after single and multiple dose administration according to H. pylori infection. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CJ-12420 50mg(HP-), CJ-12420 100mg(HP-) and CJ-12420 50mg(HP+)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Apr 2016
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers between 20 to 45 years of age (inclusive)
- Body mass index (BMI) in the range of 19~28 kg/㎡ and weighted at least 50kg
- Medically healthy with no clinically significant vital signs (blood pressure in the sitting position, pulse rate)
- 90 mmHg ≤ systolic blood pressure ≤ 140 mmHg
- 50 mmHg ≤ diastolic blood pressure ≤ 95 mmHg
- 45 beats per minute ≤ pulse rate ≤ 95 beats per minute
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- Understood the requirements of the study and voluntarily consented to participate in the study
- Agreed to be sexually abstinent or to use a condom or spermicide when engaging in sexual activity and not to donate sperm during the course of the study for 30 days following completion of the study
- Non-smokers or non-users of nicotine-containing products for at least 1 year
- [Cohort 1] H. pylori negative as determined by urea breath test and serum IgG antibody
- [Cohort 2] H. pylori positive as determined by urea breath test and serum IgG
Who cannot join
- History of clinically significant gastrointestinal, renal, hepatic, neurologic, hemato-oncologic, endocrine, pulmonary, immunologic, psychiatric, musculoskeletal, or cardiovascular disease or any other condition, which in the opinion of the investigators, would jeopardize the safety of the subject or impact the validity of the study results
- History of allergy or hypersensitivity to any drug, including prior serious adverse reaction to PPIs or P-CABs
- Undergone surgery or in a medical condition, which in the judgment of the PI or investigators may affect absorption, distribution, metabolism or elimination of the study drug
- Administered other drug(s) in other clinical study within 60 days prior to screening visit
- Donated blood within 60 days or blood components within 30 days, or had been transfused plasma within 30 days prior to screening visit
- On special diet or have experienced substantial changes in eating habits within 30 days prior to screening visit
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- Used any prescription medication within 14 days, or any other OTC medications including herbal products within 7 days prior to screening visit
- Consumed over 21 units/week of alcohol
- Consumed over 5 units/day of caffeine-containing beverage
- Positive urine screen for drugs and/or cotinine
- Positive blood screen for human immunodeficiency virus (HIV), hepatitis B or C, or syphilis
- Clinically significant abnormalities of liver function tests (≥1.5 fold of normal upper limit in the level of L-alanine aminotransferase (ALT), L-aspartate aminotransferase (AST) or total bilirubin)
- Unable to bear pH meter catheter insertion
- History of symptomatic GERD, erosive esophagitis, duodenal ulcer, gastric ulcer, Barrett's esophagus, or Zollinger-Ellison syndrome
- Clinically significant observations considered as unsuitable based on medical judgment by investigators
About this study
Official title: A Phase I , Study to Investigate Pharmacokinetics and Pharmacodynamics of Single and Multiple Dose of CJ-12420 50mg, 100mg in Helicobacter Pylori ?
The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of CJ-12420 after single and multiple dose administration according to H. pylori infection.
Read the detailed description
- Cohort 1: To investigate the pharmacokinetics and pharmacodynamics of CJ-12420 after the multiple dose administration in H. pylori negative volunteers.
- Cohort 2: To investigate the pharmacokinetics and pharmacodynamics of CJ-12420 after the single dose administration in H. pylori positive volunteers.
- Conditions
- Healthy
- Being tested
- CJ-12420 50mg(HP-), CJ-12420 100mg(HP-), CJ-12420 50mg(HP+), CJ-12420 100mg(HP+)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CJ-12420 50mg(HP-)Drug
Also called not yet determined
CJ-12420 50mg in H. pylori negative subject
CJ-12420 100mg(HP-)Drug
Also called not yet determined
CJ-12420 100mg in H. pylori negative subject
CJ-12420 50mg(HP+)Drug
Also called not yet determined
CJ-12420 50mg in H. pylori positive subject
CJ-12420 100mg(HP+)Drug
Also called not yet determined
CJ-12420 100mg in H. pylori positive subject
| Study group | Role | What they receive |
|---|---|---|
| CJ-12420 50mg(HP-) | Experimental | CJ-12420 50mg in H. pylori negative subject Receives: Drug: CJ-12420 50mg(HP-) |
| CJ-12420 100mg(HP-) | Experimental | CJ-12420 100mg in H. pylori negative subject Receives: Drug: CJ-12420 100mg(HP-) |
| CJ-12420 50mg(HP+) | Experimental | CJ-12420 50mg in H. pylori positive subject Receives: Drug: CJ-12420 50mg(HP+) |
| CJ-12420 100mg(HP+) | Experimental | CJ-12420 100mg in H. pylori positive subject Receives: Drug: CJ-12420 100mg(HP+) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax) of CJ-12420
Measured: up to 12 hours
Secondary outcomes (6)
Area under the plasma concentration versus time curve (AUC) of CJ-12420
Measured: up to 12 hours
Time of maximum observed concentration(tmax) of CJ-12420
Measured: up to 12 hours
Half life(t1/2β) of CJ-12420
Measured: up to 12 hours
Mean pH
Data from the pH probe monitoring
Measured: Day -1, Day 1, Day 7 up to 24 hours
Time at pH > 4(%)
the percent of time the pH as data from the pH probe monitoring
Measured: Day -1, Day 1, Day 7 up to 24 hours
Time at pH > 6(%)
the percent of time the pH as data from the pH probe monitoring
Measured: Day -1, Day 1, Day 7 up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study startJan 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Asan Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009760
- Sponsor's protocol ID
- [CJ_APA_104]
- Status last verified
- Jan 2017
- First submitted
- 28 Dec 2016
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I , Study to Investigate Pharmacokinetics and Pharmacodynamics of Single and Multiple Dose of CJ-12420 50mg, 100mg in Helicobacter Pylori ?
- ClinicalTrials.gov ID
- NCT03009760
- Acronym / sponsor ID
- [CJ_APA_104]
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Asan Medical Center
- Study start
- Jan 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 4 Jan 2017 (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.
The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of CJ-12420 after single and multiple dose administration according to H. pylori infection.
Detailed description
- Cohort 1: To investigate the pharmacokinetics and pharmacodynamics of CJ-12420 after the multiple dose administration in H. pylori negative volunteers.
- Cohort 2: To investigate the pharmacokinetics and pharmacodynamics of CJ-12420 after the single dose administration in H. pylori positive volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CJ-12420 50mg(HP-) | Experimental | Drug: CJ-12420 50mg(HP-)CJ-12420 50mg in H. pylori negative subject |
| CJ-12420 100mg(HP-) | Experimental | Drug: CJ-12420 100mg(HP-)CJ-12420 100mg in H. pylori negative subject |
| CJ-12420 50mg(HP+) | Experimental | Drug: CJ-12420 50mg(HP+)CJ-12420 50mg in H. pylori positive subject |
| CJ-12420 100mg(HP+) | Experimental | Drug: CJ-12420 100mg(HP+)CJ-12420 100mg in H. pylori positive subject |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy male volunteers between 20 to 45 years of age (inclusive)
- Body mass index (BMI) in the range of 19~28 kg/㎡ and weighted at least 50kg
- Medically healthy with no clinically significant vital signs (blood pressure in the sitting position, pulse rate)
- Understood the requirements of the study and voluntarily consented to participate in the study
- Agreed to be sexually abstinent or to use a condom or spermicide when engaging in sexual activity and not to donate sperm during the course of the study for 30 days following completion of the study
Key exclusion criteria (15 listed)
- History of clinically significant gastrointestinal, renal, hepatic, neurologic, hemato-oncologic, endocrine, pulmonary, immunologic, psychiatric, musculoskeletal, or cardiovascular disease or any other condition, which in the opinion of the investigators, would jeopardize the safety of the subject or impact the validity of the study results
- History of allergy or hypersensitivity to any drug, including prior serious adverse reaction to PPIs or P-CABs
- Undergone surgery or in a medical condition, which in the judgment of the PI or investigators may affect absorption, distribution, metabolism or elimination of the study drug
- Administered other drug(s) in other clinical study within 60 days prior to screening visit
- Donated blood within 60 days or blood components within 30 days, or had been transfused plasma within 30 days prior to screening visit
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 50mg(HP-)Also: not yet determinedCJ-12420 50mg in H. pylori negative subject | Drug | CJ-12420 50mg(HP-) |
| CJ-12420 100mg(HP-)Also: not yet determinedCJ-12420 100mg in H. pylori negative subject | Drug | CJ-12420 100mg(HP-) |
| CJ-12420 50mg(HP+)Also: not yet determinedCJ-12420 50mg in H. pylori positive subject | Drug | CJ-12420 50mg(HP+) |
| CJ-12420 100mg(HP+)Also: not yet determinedCJ-12420 100mg in H. pylori positive subject | Drug | CJ-12420 100mg(HP+) |
Primary outcome
Peak Plasma Concentration (Cmax) of CJ-12420
Time frame: up to 12 hours
6 secondary outcomes
Area under the plasma concentration versus time curve (AUC) of CJ-12420
Time frame: up to 12 hours
Time of maximum observed concentration(tmax) of CJ-12420
Time frame: up to 12 hours
Half life(t1/2β) of CJ-12420
Time frame: up to 12 hours
Mean pH
Time frame: Day -1, Day 1, Day 7 up to 24 hours
Time at pH > 4(%)
Time frame: Day -1, Day 1, Day 7 up to 24 hours
Time at pH > 6(%)
Time frame: Day -1, Day 1, Day 7 up to 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 20 Jan 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CJ-12420 50mg(HP-), CJ-12420 100mg(HP-) and CJ-12420 50mg(HP+) in people with Healthy, run by HK inno.N Corporation.
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 11 inclusion and 15 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 20 Jan 2017. 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. 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?
Peak Plasma Concentration (Cmax) of CJ-12420 (time frame: up to 12 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 20 Jan 2017.