HealthyPhase 1NCT01007019
Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of YH4808 After Oral Administration in Healthy Male Subjects
A Phase 1 study testing YH4808 30mg, YH4808 50mg and YH4808 100mg in people with Healthy, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
First in human study 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 30mg, YH4808 50mg and YH4808 100mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2009to Mar 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
- Healthy male volunteers in the age between 20 to 45 years old
- Subjects who were determined to be appropriate through screening
- Weight: over 50kg, within ±20% of ideal body weight
- Subjects who signed written consent after receiving thorough explanation on trial purpose, content, and characteristics of investigational drug
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 were unable to be applicable for pH meter catheter
- Subjects who had a history of drug abuse or who had a positive results on urine drug screening
Show all 15Show fewer
- 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)
- Subjects who participated in another clinical trial within 3 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 weren't able 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
- H.pylori positive results on the Urease breath test(Only repeat doses)
- Subjects with clinically significant observations considered as unsuitable based on medical judgment by investigators
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical trials center, Seoul national university hospital
Seoul, 110-744
About this study
Official title: A Dose-block Randomized, Double-blind, Placebo/Active-controlled, Single/Multiple Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety/Tolerability and PKs/PDs of YH4808 After Oral Administration in Healthy Male Subjects
First in human study
Read the detailed description
Study to evaluate the safety and tolerability, pharmacokinetics/pharmacodynamics (PK/PD) parameters of an escalating, single dose/repeat doses of YH4808 in healthy subjects.
- Conditions
- Healthy
- Being tested
- YH4808 30mg, YH4808 50mg, YH4808 100mg, YH4808 200mg, YH4808
- Keywords
- Safety, tolerability and PK/PD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YH4808 30mgDrug
Also called YH4808 30mg (single dose)
YH4808 30mg (single dose)
YH4808 50mgDrug
Also called YH4808 50mg (single dose)
YH4808 50mg (single dose)
YH4808 100mgDrug
Also called YH4808 100mg (single dose)
YH4808 100mg (single dose)
YH4808 200mgDrug
Also called YH4808 200mg (single dose)
YH4808 200mg (single dose)
YH4808Drug
Also called YH4808 400mg (single dose)
YH4808 400mg (single dose)
YH4808 100mg (repeat dose)Drug
YH4808 100mg (repeat dose)
YH4808 200mg (repeat dose)Drug
YH4808 200mg (repeat dose)
YH4808 600mgDrug
YH4808 600mg
YH4808 800mg (single dose)Drug
YH4808 800mg (single dose)
YH4808 400 mg (repeat doses)Drug
YH4808 400 mg (repeat doses)
PlaceboDrug
Also called 10 volunteers will be administered matched placebo.
10 volunteers will be administered matched placebo.
Esomeprazole 40mgDrug
Also called 24 volunteers will be administered Esomeprazole 40mg
24 volunteers will be administered Esomeprazole 40mg
| Study group | Role | What they receive |
|---|---|---|
| YH4808 30mg | Experimental | 1.Single dose
2.12 volunteers were administered YH4808 30mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) Receives: Drug: YH4808 30mg |
| YH4808 50mg | Experimental | 1.Single dose
2.12 volunteers were administered YH4808 50mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) Receives: Drug: YH4808 50mg |
| YH4808 100mg | Experimental | 1.Single dose
2.12 volunteers were administered YH4808 100mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) Receives: Drug: YH4808 100mg |
| YH4808 200mg | Experimental | 1.Single dose
2.12 volunteers were administered YH4808 200mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) Receives: Drug: YH4808 200mg |
| YH4808 400mg | Experimental | 1.Single dose
2.12 volunteers were administered YH4808 400mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) Receives: Drug: YH4808 |
| YH4808 100mg(repeat doses) | Experimental | 1.Repeat doses
2.12 volunteers were administered YH4808 100mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) Receives: Drug: YH4808 100mg (repeat dose) |
| YH4808 200mg(repeat doses) | Experimental | 1.Repeat doses
2.16 volunteers were administered YH4808 200mg or active/placebo comparators.(YH4808:active:placebo=8:6:2) Receives: Drug: YH4808 200mg (repeat dose) |
| YH4808 400mg(repeat doses) | Experimental | 1.Repeat dose
2.12 volunteers were administered YH4808 400mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) Receives: Drug: YH4808 400 mg (repeat doses) |
| YH4808 600mg | Experimental | 1.Single dose
2.12 volunteers were administered YH4808 600mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) Receives: Drug: YH4808 600mg |
| YH4808 800mg | Experimental | 1.Single dose
2.12 volunteers were administered YH4808 800mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) Receives: Drug: YH4808 800mg (single dose) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Esomeprazole 40mg | Active comparator | Not described Receives: Drug: Esomeprazole 40mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the PKs, PDs, safety and tolerability of escalating, single/multiple oral doses of YH4808
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 posted3 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionMar 2011
- Study completionMar 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 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 134 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
- NCT01007019
- Sponsor's protocol ID
- YCD142 (YH4808-101)
- Status last verified
- Jul 2014
- First submitted
- 2 Nov 2009
- Last updated
- 10 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-block Randomized, Double-blind, Placebo/Active-controlled, Single/Multiple Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety/Tolerability and PKs/PDs of YH4808 After Oral Administration in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01007019
- Acronym / sponsor ID
- YCD142 (YH4808-101)
- Conditions
- Healthy
- Keywords
- Safety, tolerability and PK/PD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 3 Nov 2009 (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.
First in human study
Detailed description
Study to evaluate the safety and tolerability, pharmacokinetics/pharmacodynamics (PK/PD) parameters of an escalating, single dose/repeat doses of YH4808 in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| YH4808 30mg | Experimental | Drug: YH4808 30mg1.Single dose 2.12 volunteers were administered YH4808 30mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) |
| YH4808 50mg | Experimental | Drug: YH4808 50mg1.Single dose 2.12 volunteers were administered YH4808 50mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) |
| YH4808 100mg | Experimental | Drug: YH4808 100mg1.Single dose 2.12 volunteers were administered YH4808 100mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) |
| YH4808 200mg | Experimental | Drug: YH4808 200mg1.Single dose 2.12 volunteers were administered YH4808 200mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) |
| YH4808 400mg | Experimental | Drug: YH48081.Single dose 2.12 volunteers were administered YH4808 400mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) |
| YH4808 100mg(repeat doses) | Experimental | Drug: YH4808 100mg (repeat dose)1.Repeat doses 2.12 volunteers were administered YH4808 100mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) |
| YH4808 200mg(repeat doses) | Experimental | Drug: YH4808 200mg (repeat dose)1.Repeat doses 2.16 volunteers were administered YH4808 200mg or active/placebo comparators.(YH4808:active:placebo=8:6:2) |
| YH4808 400mg(repeat doses) | Experimental | Drug: YH4808 400 mg (repeat doses)1.Repeat dose 2.12 volunteers were administered YH4808 400mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) |
| YH4808 600mg | Experimental | Drug: YH4808 600mg1.Single dose 2.12 volunteers were administered YH4808 600mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) |
| YH4808 800mg | Experimental | Drug: YH4808 800mg (single dose)1.Single dose 2.12 volunteers were administered YH4808 800mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) |
| Placebo | Placebo comparator | Drug: Placebo |
| Esomeprazole 40mg | Active comparator | Drug: Esomeprazole 40mg |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male volunteers in the age between 20 to 45 years old
- Subjects who were determined to be appropriate through screening
- Weight: over 50kg, within ±20% of ideal body weight
- Subjects who signed written consent after receiving thorough explanation on trial purpose, content, and characteristics of investigational drug
Key exclusion criteria (15 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 were unable to be applicable for pH meter catheter
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 30mgAlso: YH4808 30mg (single dose)YH4808 30mg (single dose) | Drug | YH4808 30mg |
| YH4808 50mgAlso: YH4808 50mg (single dose)YH4808 50mg (single dose) | Drug | YH4808 50mg |
| YH4808 100mgAlso: YH4808 100mg (single dose)YH4808 100mg (single dose) | Drug | YH4808 100mg |
| YH4808 200mgAlso: YH4808 200mg (single dose)YH4808 200mg (single dose) | Drug | YH4808 200mg |
| YH4808Also: YH4808 400mg (single dose)YH4808 400mg (single dose) | Drug | YH4808 400mg |
| YH4808 100mg (repeat dose)YH4808 100mg (repeat dose) | Drug | YH4808 100mg(repeat doses) |
| YH4808 200mg (repeat dose)YH4808 200mg (repeat dose) | Drug | YH4808 200mg(repeat doses) |
| YH4808 600mgYH4808 600mg | Drug | YH4808 600mg |
| YH4808 800mg (single dose)YH4808 800mg (single dose) | Drug | YH4808 800mg |
| YH4808 400 mg (repeat doses)YH4808 400 mg (repeat doses) | Drug | YH4808 400mg(repeat doses) |
| PlaceboAlso: 10 volunteers will be administered matched placebo.10 volunteers will be administered matched placebo. | Drug | Placebo |
| Esomeprazole 40mgAlso: 24 volunteers will be administered Esomeprazole 40mg24 volunteers will be administered Esomeprazole 40mg | Drug | Esomeprazole 40mg |
Primary outcome
To evaluate the PKs, PDs, safety and tolerability of escalating, single/multiple oral doses of YH4808
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 Jul 2014.
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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 30mg, YH4808 50mg and YH4808 100mg 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 15 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 Jul 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. Some participants in this study may receive a placebo. 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 PKs, PDs, safety and tolerability of escalating, single/multiple oral doses of YH4808 (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 Jul 2014.