HealthyPhase 1NCT01761513

YH4808 Postprandial PK/PD Study in Healthy Subjects

A Phase 1 study testing YH4808 in people with Healthy, run by Yuhan Corporation at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

A clinical Study to evaluate the safety and pharmacokinetics/pharmacodynamics(PK/PD) of YH4808 after repeated Oral administration and Postprandial state in healthy volunteers Read more about this study

Who is it for?: Ages 20 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: YH4808
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteSouth Korea
Study dates: Nov 2012to Feb 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 20 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male and female aged 20 to 55 with a body mass index(BMI) between 18.5 and 25 kg/m2
Subject who has no congenital, chronic diseases and disease symptoms in medical examination result
Subject who shows negative reaction of UBT(Urea Breath Test)
Subject who is judged to be eligible by principal investigator or sub-investigator according to various reasons including their abnormal test results (clinical laboratory test, chest X-ray test, 12-lead ECG etc) 4 weeks before the first IP adminitration
Medically acceptable contraception(including individuals who are medically unable to become pregnant) used during the clinical trial
Volunteers who has signed a written informed consent voluntarily, prior to any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug

Who cannot join

Subject who is hypersensitive to components contained in YH4808 or this drug
Subject who has history or presence of clinically significant diseases in liver, kidney, gastrointestinal tract, nervous system, respiratory system, endocrine system, blood tumor, cardiovascular, urinary system, and mental disorder
Subject who has history of surgical operation or diseases related to gastrointestinal symtem (e.g. crohn's disaese, ulcer etc except appendectomy or simple for herina)
Other exclusions apply

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Yonsei University Health System(Severance Hospital)
Seoul, Seodaemun-gu,Sinchon-dong, 120-752

Other trials in South Korea

About this study

Official title: A Randomized,Open Label,Active-controlled, Multiple Dosing and Crossover Clinical Trial to Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of YH4808 After Postprandial Oral Administration in Healthy Volunteers

A clinical Study to evaluate the safety and pharmacokinetics/pharmacodynamics(PK/PD) of YH4808 after repeated Oral administration and Postprandial state in healthy volunteers

Conditions: Healthy
Being tested: YH4808

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

YH4808Drug
Group1
1. adminitration of YH4808 dose1, bid for 2weeks
2. wash-out period for 3weeks between period1 and period2
3. adminitration of YH4808 dose2, qd for 2weeks
YH4808Drug
Group2
1. adminitration of YH4808 dose2, qd for 2weeks
2. wash-out period for 3weeks between period1 and period2
3. adminitration of YH4808 dose1, bid for 2weeks
YH4808Drug
Also called YH4808, Nexium
Group3
1. adminitration of YH4808 dose2, bid for 2weeks
2. wash-out period for 3weeks between period1 and period2
3. adminitration of Nexium tab 40mg, bid for 2weeks
YH4808Drug
Also called Nexium
Group 4
1. adminitration of Nexium tab 40mg, bid for 2weeks
2. wash-out period for 3weeks between period1 and period2
3. adminitration of YH4808 dose2, bid for 2weeks

Study groups in NCT01761513
Study group	Role	What they receive
Sequence 1	Experimental	Not described Receives: Drug: YH4808
Sequence 2	Experimental	Not described Receives: Drug: YH4808
Sequence 3	Active comparator	Not described Receives: Drug: YH4808
Sequence 4	Active comparator	Not described Receives: Drug: YH4808

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
Measured: Blood sampling during 0 ~ 24 hrs after administration
Peak plasma concentration of YH4808
Measured: Blood sampling during 0~24 hrs after administration

Secondary outcomes (1)

Time to reach peak plasma concentration of YH4808
Measured: Blood sampling during 0 ~ 24 hrs after administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2012Feb 2014

First posted4 Jan 2013 (estimated)
Study startNov 2012
Primary completionFeb 2013
Study completionFeb 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 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: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01761513
Sponsor's protocol ID: YH4808-107
Status last verified: Apr 2014
First submitted: 2 Jan 2013
Last updated: 15 Apr 2014
Results posted: No
Data monitoring committee: No

Publications

Yoon S, Oh E, Park MS, Jang SB, Byun HM, Park H, Kim H, Kim CO. Comparison of the pharmacokinetics and pharmacodynamics of YH4808 in healthy subjects for defining an appropriate dosing regimen. Transl Clin Pharmacol. 2021 Sep;29(3):150-159. doi: 10.12793/tcp.2021.29.e15. Epub 2021 Sep 17.
PubMed 34621707

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized,Open Label,Active-controlled, Multiple Dosing and Crossover Clinical Trial to Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of YH4808 After Postprandial Oral Administration in Healthy Volunteers
ClinicalTrials.gov ID: NCT01761513
Acronym / sponsor ID: YH4808-107
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Yuhan CorporationIndustry (pharma, biotech, devices)
Study start: Nov 2012
Primary completion: Feb 2013 (actual)
Study completion: Feb 2014 (actual)
First posted: 4 Jan 2013 (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.

A clinical Study to evaluate the safety and pharmacokinetics/pharmacodynamics(PK/PD) of YH4808 after repeated Oral administration and Postprandial state in healthy volunteers

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Sequence 1	Experimental	Drug: YH4808
Sequence 2	Experimental	Drug: YH4808
Sequence 3	Active comparator	Drug: YH4808
Sequence 4	Active comparator	Drug: YH4808

Who may qualify

Ages: 20 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Healthy male and female aged 20 to 55 with a body mass index(BMI) between 18.5 and 25 kg/m2
Subject who has no congenital, chronic diseases and disease symptoms in medical examination result
Subject who shows negative reaction of UBT(Urea Breath Test)
Subject who is judged to be eligible by principal investigator or sub-investigator according to various reasons including their abnormal test results (clinical laboratory test, chest X-ray test, 12-lead ECG etc) 4 weeks before the first IP adminitration
Medically acceptable contraception(including individuals who are medically unable to become pregnant) used during the clinical trial

Key exclusion criteria (4 listed)

Subject who is hypersensitive to components contained in YH4808 or this drug
Subject who has history or presence of clinically significant diseases in liver, kidney, gastrointestinal tract, nervous system, respiratory system, endocrine system, blood tumor, cardiovascular, urinary system, and mental disorder
Subject who has history of surgical operation or diseases related to gastrointestinal symtem (e.g. crohn's disaese, ulcer etc except appendectomy or simple for herina)
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
YH4808Group1 1. adminitration of YH4808 dose1, bid for 2weeks 2. wash-out period for 3weeks between period1 and period2 3. adminitration of YH4808 dose2, qd for 2weeks	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4
YH4808Group2 1. adminitration of YH4808 dose2, qd for 2weeks 2. wash-out period for 3weeks between period1 and period2 3. adminitration of YH4808 dose1, bid for 2weeks	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4
YH4808Also: YH4808, NexiumGroup3 1. adminitration of YH4808 dose2, bid for 2weeks 2. wash-out period for 3weeks between period1 and period2 3. adminitration of Nexium tab 40mg, bid for 2weeks	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4
YH4808Also: NexiumGroup 4 1. adminitration of Nexium tab 40mg, bid for 2weeks 2. wash-out period for 3weeks between period1 and period2 3. adminitration of YH4808 dose2, bid for 2weeks	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4

Primary outcome

Area under the plasma concentration versus time curve of YH4808
Time frame: Blood sampling during 0 ~ 24 hrs after administration
Peak plasma concentration of YH4808
Time frame: Blood sampling during 0~24 hrs after administration

1 secondary outcome

Time to reach peak plasma concentration of YH4808
Time frame: Blood sampling during 0 ~ 24 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 15 Apr 2014.
Derived from this study: PubMed 34621707Yoon S, Oh E, Park MS, Jang SB, Byun HM, Park H, Kim H, Kim CO. Comparison of the pharmacokinetics and pharmacodynamics of YH4808 in healthy subjects for defining an appropriate dosing regimen. Transl Clin Pharmacol. 2021 Sep;29(3):150-159. doi: 10.12793/tcp.2021.29.e15. Epub 2021 Sep 17.

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

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.

Minsoo Park, Ph.D, M.D. principal investigator

Yonsei University Health System, Severance 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 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 6 inclusion and 4 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 Apr 2014. 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 0 ~ 24 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 NCT01761513, 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 Apr 2014.