HealthyPhase 1NCT02176668
The Exploration for Pharmacodynamics and Pharmacokinetics of YH4808 New Formulation in Healthy Subjects
A Phase 1 study testing YH4808 NF 100, YH4808 OF 200 and YH4808 NF 200 in people with Healthy, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
The objective of this clinical trial is to explore pharmacodynamics and pharmacokinetics of YH4808 New Formulation in healthy volunteers. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- YH4808 NF 100, YH4808 OF 200 and YH4808 NF 200
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy adult age 20 to 55 over 55kg with ideal body weight(BMI) 18.5 ~ 25
- Subject who has no congenital, chronic disease and disease symptoms in medical examination result
- negative to Helicobacter pylori in 13C urea breath test
- Subject who judged to be eligible according to various test results including laboratory test(serum test, hematologic/blood chemistry examination, urine test, etc.) and 12-lead ECG test performed within 4 weeks before the first IP administration.
- Subject who agreed to maintain contraception and comply with medically verified contraception methods (including infertility)
Who cannot join
- Subject who has history or presence of clinically significant disease in liver, kidney, nervous system, respiratory system, endocrine system, blood tumor, cardiovascular, reproductive, musculoskeletal system, mental disorder, ophthalmologic disease, and skin disease in investigator's judgement.
- Subject who has history of surgical operation or disease related to gastrointestinal symptoms (e.g. crohn's diseas, ulcer, etc. except for appendectomy or simple hernia) which could have influence on the absorption of IP.
- Subject who is hypersensitive to components contained in YH4808 and other drugs(aspirin, antibiotics, etc.)
- pregnant or lactating woman.
- Other exclusions apply.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei Medical Center Severance Hospital Clinical Trials Center
Seoul
About this study
Official title: A Randomized, Open-label, Multiple-dose, Partial Crossover Study to Explore the Pharmacokinetics and the Pharmacodynamics of YH4808 New Formulation in Healthy Subjects
The objective of this clinical trial is to explore pharmacodynamics and pharmacokinetics of YH4808 New Formulation in healthy volunteers.
- Conditions
- Healthy
- Being tested
- YH4808 NF 100, YH4808 OF 200, YH4808 NF 200, YH4808 NF 400
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YH4808 NF 100Drug
The number of times : multiple-dose Rout : oral administration
YH4808 OF 200Drug
The number of times : multiple-dose Rout : oral administration
YH4808 NF 200Drug
The number of times : multiple-dose Rout : oral administration
YH4808 NF 400Drug
The number of times : multiple-dose Rout : oral administration
| Study group | Role | What they receive |
|---|---|---|
| Cohort1-YH4808 NF 100 | Experimental | 7 days repeat administration of YH4808 New Formulation 100mg after meal Receives: Drug: YH4808 NF 100 |
| Cohort1-YH4808 OF 200 | Experimental | (Partial cross over design) 7 days repeat administration of YH4808 Old Formulation 200mg after meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 New Formulation 200mg after meal Receives: Drug: YH4808 OF 200; Drug: YH4808 NF 200 |
| Cohort1-YH4808 NF 200 | Experimental | (Partial cross over design) 7 days repeat administration of YH4808 New Formulation 200mg after meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg after meal Receives: Drug: YH4808 OF 200; Drug: YH4808 NF 200 |
| Cohort1-YH4808 NF 400 | Experimental | 7 days repeat administration of YH4808 New Formulation 400mg after meal Receives: Drug: YH4808 NF 400 |
| Cohort2-YH4808 NF 100 | Experimental | 7 days repeat administration of YH4808 New Formulation 100mg before meal Receives: Drug: YH4808 NF 100 |
| Cohort2-YH4808 NF 200 | Experimental | (Partial cross over design) 7 days repeat administration of YH4808 New Formulation 200mg before meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before meal Receives: Drug: YH4808 OF 200; Drug: YH4808 NF 200 |
| Cohort2-YH4808 OF 200 | Experimental | (Partial cross over design) 7 days repeat administration of YH4808 New Formulation 200mg before meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before meal Receives: Drug: YH4808 OF 200; Drug: YH4808 NF 200 |
| Cohort2-YH4808 NF 400 | Experimental | 7 days repeat administration of YH4808 New Formulation 400mg before meal Receives: Drug: YH4808 NF 400 |
| Cohort3-YH4808 OF 200 | Experimental | (Partial cross over design)
1. 7 days repeat administration of YH4808 Old Formulation 200mg before bed, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before dinner
2. 7 days repeat administration of YH4808 Old Formulation 200mg before dinner, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before bed Receives: Drug: YH4808 OF 200 |
| Cohort3-YH4808 OF 400 | Experimental | (Partial cross over design)
1. 7 days repeat administration of YH4808 Old Formulation 400mg before bed, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 400mg before dinner
2. 7 days repeat administration of YH4808 Old Formulation 400mg before dinner, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 400mg before bed Receives: Drug: YH4808 OF 200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Cmax of YH4808
Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing
Measured: Day 1(Day 35), Day 7(Day 41)
The AUC0-24h of YH4808
Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing
Measured: Day 1(Day 35), Day 7(Day 41)
The AUC0-24h of M3
Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing
Measured: Day 1(Day 35), Day 7(Day 41)
The Cmax of M3
Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing
Measured: Day 1(Day 35), Day 7(Day 41)
Secondary outcomes (3)
the arithmetic mean of 24h intragastric pH monitoring
Measured: Day 1(Day7)~Day2(Day8)
the median of 24h intragastric pH monitoring
Measured: Day 1(Day7)~Day2(Day8)
The Duration of stomach maintained over pH4 or 5
Measured: Day 1(Day7)~Day2(Day8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionNov 2014
- Study completionNov 2014
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 Yuhan 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min soo Park, Ph.D, M.D., Principal investigator, Yonsei Medical Center Severance Hospital Clinical Trials Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176668
- Sponsor's protocol ID
- YH4808-111
- Status last verified
- Feb 2015
- First submitted
- 11 Jun 2014
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multiple-dose, Partial Crossover Study to Explore the Pharmacokinetics and the Pharmacodynamics of YH4808 New Formulation in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02176668
- Acronym / sponsor ID
- YH4808-111
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 27 Jun 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.
The objective of this clinical trial is to explore pharmacodynamics and pharmacokinetics of YH4808 New Formulation in healthy volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Cohort1-YH4808 NF 100 | Experimental | Drug: YH4808 NF 1007 days repeat administration of YH4808 New Formulation 100mg after meal |
| Cohort1-YH4808 OF 200 | Experimental | Drug: YH4808 OF 200, Drug: YH4808 NF 200(Partial cross over design) 7 days repeat administration of YH4808 Old Formulation 200mg after meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 New Formulation 200mg after meal |
| Cohort1-YH4808 NF 200 | Experimental | Drug: YH4808 OF 200, Drug: YH4808 NF 200(Partial cross over design) 7 days repeat administration of YH4808 New Formulation 200mg after meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg after meal |
| Cohort1-YH4808 NF 400 | Experimental | Drug: YH4808 NF 4007 days repeat administration of YH4808 New Formulation 400mg after meal |
| Cohort2-YH4808 NF 100 | Experimental | Drug: YH4808 NF 1007 days repeat administration of YH4808 New Formulation 100mg before meal |
| Cohort2-YH4808 NF 200 | Experimental | Drug: YH4808 OF 200, Drug: YH4808 NF 200(Partial cross over design) 7 days repeat administration of YH4808 New Formulation 200mg before meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before meal |
| Cohort2-YH4808 OF 200 | Experimental | Drug: YH4808 OF 200, Drug: YH4808 NF 200(Partial cross over design) 7 days repeat administration of YH4808 New Formulation 200mg before meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before meal |
| Cohort2-YH4808 NF 400 | Experimental | Drug: YH4808 NF 4007 days repeat administration of YH4808 New Formulation 400mg before meal |
| Cohort3-YH4808 OF 200 | Experimental | Drug: YH4808 OF 200(Partial cross over design) 1. 7 days repeat administration of YH4808 Old Formulation 200mg before bed, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before dinner 2. 7 days repeat administration of YH4808 Old Formulation 200mg before dinner, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before bed |
| Cohort3-YH4808 OF 400 | Experimental | Drug: YH4808 OF 200(Partial cross over design) 1. 7 days repeat administration of YH4808 Old Formulation 400mg before bed, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 400mg before dinner 2. 7 days repeat administration of YH4808 Old Formulation 400mg before dinner, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 400mg before bed |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy adult age 20 to 55 over 55kg with ideal body weight(BMI) 18.5 ~ 25
- Subject who has no congenital, chronic disease and disease symptoms in medical examination result
- negative to Helicobacter pylori in 13C urea breath test
- Subject who judged to be eligible according to various test results including laboratory test(serum test, hematologic/blood chemistry examination, urine test, etc.) and 12-lead ECG test performed within 4 weeks before the first IP administration.
- Subject who agreed to maintain contraception and comply with medically verified contraception methods (including infertility)
Key exclusion criteria (5 listed)
- Subject who has history or presence of clinically significant disease in liver, kidney, nervous system, respiratory system, endocrine system, blood tumor, cardiovascular, reproductive, musculoskeletal system, mental disorder, ophthalmologic disease, and skin disease in investigator's judgement.
- Subject who has history of surgical operation or disease related to gastrointestinal symptoms (e.g. crohn's diseas, ulcer, etc. except for appendectomy or simple hernia) which could have influence on the absorption of IP.
- Subject who is hypersensitive to components contained in YH4808 and other drugs(aspirin, antibiotics, etc.)
- pregnant or lactating woman.
- Other exclusions apply.
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 |
|---|---|---|
| YH4808 NF 100The number of times : multiple-dose Rout : oral administration | Drug | Cohort1-YH4808 NF 100, Cohort2-YH4808 NF 100 |
| YH4808 OF 200The number of times : multiple-dose Rout : oral administration | Drug | Cohort1-YH4808 NF 200, Cohort1-YH4808 OF 200, Cohort2-YH4808 NF 200, Cohort2-YH4808 OF 200, Cohort3-YH4808 OF 200, Cohort3-YH4808 OF 400 |
| YH4808 NF 200The number of times : multiple-dose Rout : oral administration | Drug | Cohort1-YH4808 NF 200, Cohort1-YH4808 OF 200, Cohort2-YH4808 NF 200, Cohort2-YH4808 OF 200 |
| YH4808 NF 400The number of times : multiple-dose Rout : oral administration | Drug | Cohort1-YH4808 NF 400, Cohort2-YH4808 NF 400 |
Primary outcome
The Cmax of YH4808
Time frame: Day 1(Day 35), Day 7(Day 41)
Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing
The AUC0-24h of YH4808
Time frame: Day 1(Day 35), Day 7(Day 41)
Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing
The AUC0-24h of M3
Time frame: Day 1(Day 35), Day 7(Day 41)
Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing
The Cmax of M3
Time frame: Day 1(Day 35), Day 7(Day 41)
Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing
3 secondary outcomes
the arithmetic mean of 24h intragastric pH monitoring
Time frame: Day 1(Day7)~Day2(Day8)
the median of 24h intragastric pH monitoring
Time frame: Day 1(Day7)~Day2(Day8)
The Duration of stomach maintained over pH4 or 5
Time frame: Day 1(Day7)~Day2(Day8)
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 13 Jan 2022.
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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.
Min soo Park, Ph.D, M.D. principal investigator
Yonsei Medical Center Severance Hospital Clinical Trials 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 YH4808 NF 100, YH4808 OF 200 and YH4808 NF 200 in people with Healthy, run by Yuhan 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 5 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 13 Jan 2022. 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 Cmax of YH4808 (time frame: Day 1(Day 35), Day 7(Day 41)). The study lists 4 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 13 Jan 2022; AzTrials last refreshed its copy on 8 Nov 2026.