HealthyPhase 1NCT02052336
Drug-Drug Interaction Study Between CJ-12420 and Clarithromycin in Healthy Male Subjects
A Phase 1 study testing CJ-12420 200mg + Clarithromycin 500mg, CJ-12420 200mg and Clarithromycin 500mg in people with Healthy, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
Primary Objective: To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin. Secondary Objective(s): To assess the safety of the coadministration of multiple dose of CJ-12420 and clarithromycin in healthy subjects 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
- Healthy
- What is being tested?
- CJ-12420 200mg + Clarithromycin 500mg, CJ-12420 200mg and Clarithromycin 500mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2013to Nov 2014
- 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 volunteers in the age between 19 and 45 years old
- Body mass index(BMI) in the range of 19 to 28 kg/m2
- Understand the requirement of the study and voluntarily consent to paticipate in the study
Who cannot join
- History of clinically significant medical history or disease (hepatic, kidney, gastrointestinal,respiratory, musculoskeletal, endocrine,neuro-psychiatric, haemato-oncologic,urinary tract, cardiac arrhythmia and cardiovascular system) judged by investigator.
- Clinically significant abnormal laboratory results within at least 28 days prior to the first day of drug administration. AST or ALT > 1.25 times of upper limit value Total bilirubin > 1.5 times of upper limit value estimated GFR :less than 80 mL/min
- Clinically significant abnormal ECG results within at least 28 days prior to the first day of drug administration PR ≥ 210 msec QRS ≥ 120 msec QT ≥ 500 msec QTcF ≥ 500 msec
- Clinically significant hypersensitivity reaction against investigational drug or other drugs
- history of drug abuse or "positive" results from drug screening test.
- Take medicine such as prescription medicine or herbal medicine, over-the-counter drug, vitamin supplements
Show all 9Show fewer
- Person who have intake history of food or drug which can affect drug absorption, drug distribution, drug metabolism, and drug excretion and bowel activity
- Volunteer have a history of donation of whole blood donation, apheresis, transfusion
- Volunteer a heavy drinker(30g/day), smoker(10 cigarettes/day), heavy caffeine consumer(400mg/day)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Inje university college of medicine Busan Paik Hospital
Busan
About this study
Official title: An Open-label, Randomized, 6-Sequence, 3-Period Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between CJ-12420 and Clarithromycin in Healthy Male Subjects
Primary Objective: To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.
Secondary Objective(s): To assess the safety of the coadministration of multiple dose of CJ-12420 and clarithromycin in healthy subjects
Read the detailed description
An open-label, randomized, 6-sequence, 3-period, 3-treatment crossover design
- Conditions
- Healthy
- Being tested
- CJ-12420 200mg + Clarithromycin 500mg, CJ-12420 200mg, Clarithromycin 500mg
- Keywords
- Drug-Drug interaction, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CJ-12420 200mg + Clarithromycin 500mgDrug
Also called CJ-12420 200mg for 5 days + Clarithromycin 500mg for 5 days
To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.
CJ-12420 200mgDrug
Also called CJ-12420 200mg for 5 days
To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.
Clarithromycin 500mgDrug
Also called Clarithromycin 500mg for 5 days
To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.
| Study group | Role | What they receive |
|---|---|---|
| CJ-12420 200 mg + Clarithromycin 500mg | Experimental | CJ-12420 200mg QD for 5 days + Clarithromycin 500mg BID for 5 days Receives: Drug: CJ-12420 200mg; Drug: Clarithromycin 500mg |
| CJ-12420 200mg | Active comparator | CJ-12420 200mg QD for 5 days Receives: Drug: CJ-12420 200mg + Clarithromycin 500mg; Drug: Clarithromycin 500mg |
| Clarithromycin 500mg | Active comparator | Clarithromycin 500mg BID for 5 days Receives: Drug: CJ-12420 200mg + Clarithromycin 500mg; Drug: CJ-12420 200mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin
Cmax, Cmin, Tmax, AUC(tau), CL/F, T1/2
Measured: Blood sampling during 12 or 24hrs after administration
Secondary outcomes (1)
The safety of the coadministration of multiple dose of CJ-12420 and clarithromycin in healthy subjects
Safety and tolerability parameters will include laboratory (haematology, clinical chemistry, urinalysis, 12-lead ECG) values at Screening, Day-1 and Day 6 at each period and Follow-up.
Measured: 6 days after last visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startOct 2013
- Primary completionJan 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052336
- Sponsor's protocol ID
- CJ_APA_103
- Status last verified
- Dec 2016
- First submitted
- 7 Jan 2014
- Last updated
- 15 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Oh M, Lee H, Kim S, Kim B, Song GS, Shin JG, Ghim JL. Evaluation of pharmacokinetic drug-drug interaction between tegoprazan and clarithromycin in healthy subjects. Transl Clin Pharmacol. 2023 Jun;31(2):114-123. doi: 10.12793/tcp.2023.31.e11. Epub 2023 Jun 27.
PubMed 37440779
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, 6-Sequence, 3-Period Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between CJ-12420 and Clarithromycin in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02052336
- Acronym / sponsor ID
- CJ_APA_103
- Conditions
- Healthy
- Keywords
- Drug-Drug interaction, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 3 Feb 2014 (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.
Primary Objective: To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.
Secondary Objective(s): To assess the safety of the coadministration of multiple dose of CJ-12420 and clarithromycin in healthy subjects
Detailed description
An open-label, randomized, 6-sequence, 3-period, 3-treatment crossover design
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CJ-12420 200 mg + Clarithromycin 500mg | Experimental | Drug: CJ-12420 200mg, Drug: Clarithromycin 500mgCJ-12420 200mg QD for 5 days + Clarithromycin 500mg BID for 5 days |
| CJ-12420 200mg | Active comparator | Drug: CJ-12420 200mg + Clarithromycin 500mg, Drug: Clarithromycin 500mgCJ-12420 200mg QD for 5 days |
| Clarithromycin 500mg | Active comparator | Drug: CJ-12420 200mg + Clarithromycin 500mg, Drug: CJ-12420 200mgClarithromycin 500mg BID for 5 days |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male volunteers in the age between 19 and 45 years old
- Body mass index(BMI) in the range of 19 to 28 kg/m2
- Understand the requirement of the study and voluntarily consent to paticipate in the study
Key exclusion criteria (9 listed)
- History of clinically significant medical history or disease (hepatic, kidney, gastrointestinal,respiratory, musculoskeletal, endocrine,neuro-psychiatric, haemato-oncologic,urinary tract, cardiac arrhythmia and cardiovascular system) judged by investigator.
- Clinically significant abnormal laboratory results within at least 28 days prior to the first day of drug administration. AST or ALT > 1.25 times of upper limit value Total bilirubin > 1.5 times of upper limit value estimated GFR :less than 80 mL/min
- Clinically significant abnormal ECG results within at least 28 days prior to the first day of drug administration PR ≥ 210 msec QRS ≥ 120 msec QT ≥ 500 msec QTcF ≥ 500 msec
- Clinically significant hypersensitivity reaction against investigational drug or other drugs
- history of drug abuse or "positive" results from drug screening test.
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 200mg + Clarithromycin 500mgAlso: CJ-12420 200mg for 5 days + Clarithromycin 500mg for 5 daysTo assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin. | Drug | CJ-12420 200mg, Clarithromycin 500mg |
| CJ-12420 200mgAlso: CJ-12420 200mg for 5 daysTo assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin. | Drug | CJ-12420 200 mg + Clarithromycin 500mg, Clarithromycin 500mg |
| Clarithromycin 500mgAlso: Clarithromycin 500mg for 5 daysTo assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin. | Drug | CJ-12420 200 mg + Clarithromycin 500mg, CJ-12420 200mg |
Primary outcome
The effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin
Time frame: Blood sampling during 12 or 24hrs after administration
Cmax, Cmin, Tmax, AUC(tau), CL/F, T1/2
1 secondary outcome
The safety of the coadministration of multiple dose of CJ-12420 and clarithromycin in healthy subjects
Time frame: 6 days after last visit
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 15 Dec 2016.
- Derived from this study: PubMed 37440779Oh M, Lee H, Kim S, Kim B, Song GS, Shin JG, Ghim JL. Evaluation of pharmacokinetic drug-drug interaction between tegoprazan and clarithromycin in healthy subjects. Transl Clin Pharmacol. 2023 Jun;31(2):114-123. doi: 10.12793/tcp.2023.31.e11. Epub 2023 Jun 27.
- Individual participant dataSharing planned: Undecided
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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.
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 200mg + Clarithromycin 500mg, CJ-12420 200mg and Clarithromycin 500mg 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 3 inclusion and 9 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 15 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?
The effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin (time frame: Blood sampling during 12 or 24hrs after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02052336, which also lists 1 linked publication.
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 15 Dec 2016.