HealthyPhase 1NCT01473173
Safety, Tolerability, PK, PD of Escalating Single and Multiple Oral Doses of CJ-12420 in Healthy Male Subjects
A Phase 1 study testing CJ-12420 and Esomeprazole 40mg in people with Healthy, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
The objectives of this study are: To evaluate the safety and tolerability of single and multiple oral doses of CJ-12420 in healthy male subjects. To evaluate the single- and multiple-dose PK of orally administered CJ-12420 in healthy male subjects. 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 and Esomeprazole 40mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2011to Aug 2012
- 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
- Male volunteers in the age between 20 and 45 years old (inclusive)
- Body mass index (BMI) in the range of 19 to 28 kg/m2 and weighing at least 50 kg
- Medically healthy with no clinically significant vital signs (sitting position blood pressure, 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)
- Non-smokers or non-users of nicotine-containing products for at least 3 months
Who cannot join
- History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, musculoskeletal or cardiovascular disease or any other condition, which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results
- History of allergy or sensitivity to any drug, including any prior serious adverse reaction to PPIs (e.g. omeprazole, rabeprazole, lansoprazole)
- History of symptomatic GERD, erosive esophagitis, duodenal ulcer, gastric ulcer, Barrett's esophagus or Zollinger-Ellison syndrome, previous positive H. pylori
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study, to Investigate the Safety, Tolerability, PK and PD of Escalating Single and Multiple Oral Doses of CJ-12420 in Healthy Male Subjects
The objectives of this study are:
- To evaluate the safety and tolerability of single and multiple oral doses of CJ-12420 in healthy male subjects.
- To evaluate the single- and multiple-dose PK of orally administered CJ-12420 in healthy male subjects.
- To evaluate the single- and multiple-dose PD of orally administered CJ-12420 in healthy male subjects.
- To compare the multiple-dose pharmacodynamics (PD) of orally administered CJ-12420 and esomeprazole in healthy male subjects.
- Conditions
- Healthy
- Being tested
- CJ-12420, Esomeprazole 40mg
- Keywords
- Safety, Tolerability, Pharmacokinetics, Pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CJ-12420Drug
Esomeprazole 40mgDrug
Also called Nexium
| Study group | Role | What they receive |
|---|---|---|
| CJ-12420 50mg | Experimental | * Single dose
* 8 volunteers will be administered CJ-12420 50mg or placebo comparators.(CJ-12420:placebo=6:2) Receives: Drug: CJ-12420 |
| CJ-12420 100mg | Experimental | * Single dose
* 8 volunteers will be administered CJ-12420 100mg or placebo comparators.(CJ-12420:placebo=6:2) Receives: Drug: CJ-12420 |
| CJ-12420 200mg | Experimental | * Single dose
* 8 volunteers will be administered CJ-12420 200mg or placebo comparators.(CJ-12420:placebo=6:2) Receives: Drug: CJ-12420 |
| CJ-12420 400mg | Experimental | * Single dose
* 8 volunteers will be administered CJ-12420 400mg or placebo comparators.(CJ-12420:placebo=6:2) Receives: Drug: CJ-12420 |
| CJ-12420 100mg (repeated dose) | Experimental | Repeat doses
* 100mg is the anticipated dose
* 8 volunteers will be administered CJ-12420 100mg or placebo comparator.(CJ-12420:placebo=6:2) Receives: Drug: CJ-12420 |
| CJ-12420 200mg (repeated dose) | Experimental | Repeat doses
* 200mg is the anticipated dose
* 8 volunteers will be administered CJ-12420 200mg or placebo comparator.(CJ-12420:placebo=6:2) Receives: Drug: CJ-12420 |
| Esomeprazole 40mg | Active comparator | 8 volunteers will be administered Esomeprazole 40mg Receives: Drug: Esomeprazole 40mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the PK, PD, safety and tolerability of escalating single and multiple oral doses of CJ-12420 in healthy male subjects
Measured: Throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionAug 2012
- Study completionAug 2012
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyun-Seop Bae, MD, Ph.D, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473173
- Sponsor's protocol ID
- CJ_APA_101
- Status last verified
- Apr 2013
- First submitted
- 14 Nov 2011
- Last updated
- 10 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study, to Investigate the Safety, Tolerability, PK and PD of Escalating Single and Multiple Oral Doses of CJ-12420 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01473173
- Acronym / sponsor ID
- CJ_APA_101
- Conditions
- Healthy
- Keywords
- Safety, Tolerability, Pharmacokinetics, Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 17 Nov 2011 (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 objectives of this study are:
- To evaluate the safety and tolerability of single and multiple oral doses of CJ-12420 in healthy male subjects.
- To evaluate the single- and multiple-dose PK of orally administered CJ-12420 in healthy male subjects.
- To evaluate the single- and multiple-dose PD of orally administered CJ-12420 in healthy male subjects.
- To compare the multiple-dose pharmacodynamics (PD) of orally administered CJ-12420 and esomeprazole in healthy male subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| CJ-12420 50mg | Experimental | Drug: CJ-12420* Single dose * 8 volunteers will be administered CJ-12420 50mg or placebo comparators.(CJ-12420:placebo=6:2) |
| CJ-12420 100mg | Experimental | Drug: CJ-12420* Single dose * 8 volunteers will be administered CJ-12420 100mg or placebo comparators.(CJ-12420:placebo=6:2) |
| CJ-12420 200mg | Experimental | Drug: CJ-12420* Single dose * 8 volunteers will be administered CJ-12420 200mg or placebo comparators.(CJ-12420:placebo=6:2) |
| CJ-12420 400mg | Experimental | Drug: CJ-12420* Single dose * 8 volunteers will be administered CJ-12420 400mg or placebo comparators.(CJ-12420:placebo=6:2) |
| CJ-12420 100mg (repeated dose) | Experimental | Drug: CJ-12420Repeat doses * 100mg is the anticipated dose * 8 volunteers will be administered CJ-12420 100mg or placebo comparator.(CJ-12420:placebo=6:2) |
| CJ-12420 200mg (repeated dose) | Experimental | Drug: CJ-12420Repeat doses * 200mg is the anticipated dose * 8 volunteers will be administered CJ-12420 200mg or placebo comparator.(CJ-12420:placebo=6:2) |
| Esomeprazole 40mg | Active comparator | Drug: Esomeprazole 40mg8 volunteers will be administered Esomeprazole 40mg |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male volunteers in the age between 20 and 45 years old (inclusive)
- Body mass index (BMI) in the range of 19 to 28 kg/m2 and weighing at least 50 kg
- Medically healthy with no clinically significant vital signs (sitting position blood pressure, 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)
- Non-smokers or non-users of nicotine-containing products for at least 3 months
Key exclusion criteria (3 listed)
- History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, musculoskeletal or cardiovascular disease or any other condition, which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results
- History of allergy or sensitivity to any drug, including any prior serious adverse reaction to PPIs (e.g. omeprazole, rabeprazole, lansoprazole)
- History of symptomatic GERD, erosive esophagitis, duodenal ulcer, gastric ulcer, Barrett's esophagus or Zollinger-Ellison syndrome, previous positive H. pylori
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 | Drug | CJ-12420 100mg, CJ-12420 100mg (repeated dose), CJ-12420 200mg, CJ-12420 200mg (repeated dose), CJ-12420 400mg, CJ-12420 50mg |
| Esomeprazole 40mgAlso: Nexium | Drug | Esomeprazole 40mg |
Primary outcome
To evaluate the PK, PD, safety and tolerability of escalating single and multiple oral doses of CJ-12420 in healthy male subjects
Time frame: Throughout the study
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 10 Apr 2013.
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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.
Kyun-Seop Bae, MD, Ph.D principal investigator
Asan Medical Center
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 and Esomeprazole 40mg in people with Healthy, 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 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: finished, as of the sponsor's last update on 10 Apr 2013. 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?
To evaluate the PK, PD, safety and tolerability of escalating single and multiple oral doses of CJ-12420 in healthy male subjects (time frame: Throughout the study). 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 10 Apr 2013.