HealthyPhase 1NCT01520012
Food Effect on Pharmacokinetics of YH4808 in Healthy Male Subjects
A Phase 1 study testing YH4808 100 mg and YH4808 300 mg in people with Healthy, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
The main objective is to evaluate the food effect on the pharmacokinetic profile of YH4808 100 mg b.i.d and YH4808 300 mg after oral administration 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?
- YH4808 100 mg and YH4808 300 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2012to Jun 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
- Subjects who signed written consent after receiving thorough explanation on trial purpose, content, and characteristics of investigational drug
- Healthy male volunteers in the age between 20 to 45 years old
- Weight: over 50kg, within ±20% of ideal body weight
- Subjects who were determined to be appropriate through screening
Who cannot join
- Clinically significant disorder in liver, kidney, cardiovascular, respiratory system, endocrine system and CNS in the physical examination and clinical laboratory tests or a medical history of malignant tumor or psychological disease
- Medical history of gastrointestinal disease or acid restraining surgery, gastric/esophagus surgery (excluding appendectomy, hernia surgery)
- A history of hypersensitivity to drugs or clinically significant allergic disease
- Clinically significant abnormal values in blood chemistry(≥ 1.5 fold of normal upper limit in the levels of SGOT, SGPT)
- Subjects who had a history of drug abuse or who had a positive results on urine drug screening
- Subjects who had taken usual dose of any prescription drugs within 14 days before the treatment or who had used usual dose of OTC drugs within 7 days before the treatment(cf, be able to be enrolled in this study according to an investigatory consideration)
Show all 13Show fewer
- Subjects who participated in another clinical trial within 2 months before enrolling in this study
- Subjects who donated whole blood within 2 months or component blood within 1 month or who are donated within 1 month before the treatment
- Subjects who drank Over 21 units/week of alcohol or subjects who were unable to stop drinking alcohol during the hospitalization
- Subjects who stopped smoking within 3 months before the treatment
- Subjects who had a beverage containing grapefruits within 24hrs before the hospitalization or who had a beverage containing grapefruits during the hospitalization
- Subjects who had a beverage containing caffeine during the hospitalization
- Subjects with clinically significant observations considered as unsuitable based on medical judgment by investigators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial to Investigate the Influence of Food on Safety/Tolerability and Pharmacokinetics of YH4808 After Oral Administration in Healthy Male Subjects
The main objective is to evaluate the food effect on the pharmacokinetic profile of YH4808 100 mg b.i.d and YH4808 300 mg after oral administration in healthy male subjects.
- Conditions
- Healthy
- Being tested
- YH4808 100 mg, YH4808 300 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YH4808 100 mgDrug
Period1: YH4808 100 mg bid fasting condition for 7days Period2: YH4808 100 mg bid fed condition for 7days
YH4808 100 mgDrug
Period1: YH4808 100 mg bid fed condition for 7days Period2: YH4808 100 mg bid fasting condition for 7days
YH4808 300 mgDrug
Period1: YH4808 300 mg fasting condition Period2: YH4808 300 mg fed condition(standard meal) Period3: YH4808 300 mg fed condition(high fat meal)
YH4808 300 mgDrug
Period1: YH4808 300 mg fed condition(high fat meal) Period2: YH4808 300 mg fasting condition Period3: YH4808 300 mg fed condition(standard meal)
YH4808 300 mgDrug
Period1: YH4808 300 mg fed condition(standard meal) Period2: YH4808 300 mg fed condition(high fat meal) Period3: YH4808 300 mg fasting condition
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Not described Receives: Drug: YH4808 100 mg |
| Sequence 2 | Experimental | Not described Receives: Drug: YH4808 100 mg |
| Sequence 3 | Experimental | Not described Receives: Drug: YH4808 300 mg |
| Sequence 4 | Experimental | Not described Receives: Drug: YH4808 300 mg |
| Sequence 5 | Experimental | Not described Receives: Drug: YH4808 300 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve of YH4808
non-compartmental analysis
Measured: Blood sampling during 24 or 48 hrs after administration
Peak plasma concentration of YH4808
non-compartmental analysis
Measured: Blood sampling during 24 or 48 hrs after administration
Secondary outcomes (1)
Time to reach peak plasma concentration of YH4808
non-compartmental analysis
Measured: Blood sampling during 24 or 48 hrs after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionMay 2012
- Study completionJun 2012
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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyung-Sang Yu, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520012
- Sponsor's protocol ID
- YH4808-102
- Status last verified
- May 2012
- First submitted
- 13 Jan 2012
- Last updated
- 24 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim E, Kim A, Yi S, Kim YK, Jang SB, Byun HM, Yoon SH, Cho JY, Jang IJ, Yu KS, Lee S. Effect of food on the pharmacokinetics of YH4808, a potassium-competitive acid blocker, after single- and multiple-oral dosing in healthy subjects. Eur J Clin Pharmacol. 2018 Oct;74(10):1261-1272. doi: 10.1007/s00228-018-2502-9. Epub 2018 Jun 15.
PubMed 29907887
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Investigate the Influence of Food on Safety/Tolerability and Pharmacokinetics of YH4808 After Oral Administration in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01520012
- Acronym / sponsor ID
- YH4808-102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 27 Jan 2012 (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 main objective is to evaluate the food effect on the pharmacokinetic profile of YH4808 100 mg b.i.d and YH4808 300 mg after oral administration in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: YH4808 100 mg |
| Sequence 2 | Experimental | Drug: YH4808 100 mg |
| Sequence 3 | Experimental | Drug: YH4808 300 mg |
| Sequence 4 | Experimental | Drug: YH4808 300 mg |
| Sequence 5 | Experimental | Drug: YH4808 300 mg |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects who signed written consent after receiving thorough explanation on trial purpose, content, and characteristics of investigational drug
- Healthy male volunteers in the age between 20 to 45 years old
- Weight: over 50kg, within ±20% of ideal body weight
- Subjects who were determined to be appropriate through screening
Key exclusion criteria (13 listed)
- Clinically significant disorder in liver, kidney, cardiovascular, respiratory system, endocrine system and CNS in the physical examination and clinical laboratory tests or a medical history of malignant tumor or psychological disease
- Medical history of gastrointestinal disease or acid restraining surgery, gastric/esophagus surgery (excluding appendectomy, hernia surgery)
- A history of hypersensitivity to drugs or clinically significant allergic disease
- Clinically significant abnormal values in blood chemistry(≥ 1.5 fold of normal upper limit in the levels of SGOT, SGPT)
- Subjects who had a history of drug abuse or who had a positive results on urine drug screening
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 100 mgPeriod1: YH4808 100 mg bid fasting condition for 7days Period2: YH4808 100 mg bid fed condition for 7days | Drug | Sequence 1 |
| YH4808 100 mgPeriod1: YH4808 100 mg bid fed condition for 7days Period2: YH4808 100 mg bid fasting condition for 7days | Drug | Sequence 2 |
| YH4808 300 mgPeriod1: YH4808 300 mg fasting condition Period2: YH4808 300 mg fed condition(standard meal) Period3: YH4808 300 mg fed condition(high fat meal) | Drug | Sequence 3 |
| YH4808 300 mgPeriod1: YH4808 300 mg fed condition(high fat meal) Period2: YH4808 300 mg fasting condition Period3: YH4808 300 mg fed condition(standard meal) | Drug | Sequence 4 |
| YH4808 300 mgPeriod1: YH4808 300 mg fed condition(standard meal) Period2: YH4808 300 mg fed condition(high fat meal) Period3: YH4808 300 mg fasting condition | Drug | Sequence 5 |
Primary outcome
Area under the plasma concentration versus time curve of YH4808
Time frame: Blood sampling during 24 or 48 hrs after administration
non-compartmental analysis
Peak plasma concentration of YH4808
Time frame: Blood sampling during 24 or 48 hrs after administration
non-compartmental analysis
1 secondary outcome
Time to reach peak plasma concentration of YH4808
Time frame: Blood sampling during 24 or 48 hrs after administration
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 24 Jul 2012.
- Derived from this study: PubMed 29907887Kim E, Kim A, Yi S, Kim YK, Jang SB, Byun HM, Yoon SH, Cho JY, Jang IJ, Yu KS, Lee S. Effect of food on the pharmacokinetics of YH4808, a potassium-competitive acid blocker, after single- and multiple-oral dosing in healthy subjects. Eur J Clin Pharmacol. 2018 Oct;74(10):1261-1272. doi: 10.1007/s00228-018-2502-9. Epub 2018 Jun 15.
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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.
Kyung-Sang Yu, MD, PhD principal investigator
Seoul National 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 YH4808 100 mg and YH4808 300 mg 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 4 inclusion and 13 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 24 Jul 2012. 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?
Area under the plasma concentration versus time curve of YH4808 (time frame: Blood sampling during 24 or 48 hrs after administration). The study lists 2 primary outcomes in all. 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 NCT01520012, 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 24 Jul 2012.