HealthyPhase 1NCT01870674
Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of YH12852 After Oral Administration in Healthy Male Subjects
A Phase 1 study testing YH12852 and Prucalopride in people with Healthy, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
Study to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics(PK/PD)of YH12852 after oral administration in healthy subjects Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- YH12852 and Prucalopride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 127 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2013to Apr 2015
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male/female aged 19 to 45 with body mass index(BMI) between 18 and 25kg/m2
- Subject who has no congenital, chronic disease and disease symptoms in medical examination result
- 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, 12-lead ECG etc)
- Subjects 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 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 is hypersensitive to components contained in YH12852 or prucalopride or aspirin/antibiotics like drugs
- Medical history of gastrointestinal disease or acid restraining surgery, gastric/ esophagus surgery(excluding appendectomy, hernia surgery)
- Clinically significant abnormal values in diagnostic check within 28 days before the treatment(>1.25 fold of normal upper limit in the levels of AST or ALT, >1.5 fold of normal upper limit in the levels of Total bilirubin, < 80ml/min of Cockcroft-Gault used creatinine clearance
- Subject has over QTc interval of 550 ms or PR interval of 210 ms or QRS interval of 120 ms or QT interval of 500 ms on baseline 12-lead ECG, as determined by the Investigator
- Subject 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
Show all 13Show fewer
- Subject who participated in another clinical trail within 2 months before enrolling in this study
- subject who donated whole blood within 2 months or component blood within 1 month before the treatment
- Medically unacceptable contraception used during the clinical trial
- Subject who drank over 30g/day or were detected alcohol positive on test
- Subject who stopped smoking within 3 months before the treatment or weren't able to stop smoking during the hospitalization
- Subject 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: A Randomized, Double-blind, Placebo/Active-controlled, Single/Multiple Dose Phase 1 Clinical Study to Investigate the Safety/Tolerability and PK/PD of YH12852 After Oral Administration in Healthy Subjects
Study to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics(PK/PD)of YH12852 after oral administration in healthy subjects
- Conditions
- Healthy
- Being tested
- YH12852, Prucalopride, Placebo
- Keywords
- safety, tolerability, pharmacokinetics, pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YH12852Drug
PrucaloprideDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| YH12852 | Experimental | <SAD cohort>
* Experimental: YH12852 1mg/single dose, qd
* Experimental: YH12852 3mg/single dose, qd
* Experimental: YH12852 10mg/single dose, qd
<FSD cohort>
* Experimental: YH12852 0.5mg/single dose, qd
* Experimental: YH12852 1mg/single dose, qd
* Experimental: YH12852 2mg/single dose, qd
* Experimental: YH12852 3mg/single dose, qd
<MAD cohort>
* Experimental: YH12852 0.5mg/repeat dose, qd
* Experimental: YH12852 1mg/repeat dose, qd
* Experimental: YH12852 2mg/repeat dose, qd
* Experimental: YH12852 3mg/repeat dose, qd
* Each dosing group(except MAD cohort 0.5mg which has single treatment arm taking YH12852 only) contains 12 subjects. 12 subjects are administered YH12852 or placebo/active comparators.(YH12852:placebo:active=8:2:2) Receives: Drug: YH12852 |
| Prucalopride | Active comparator | <each cohort> Prucalopride succinate 1.321mg Receives: Drug: Prucalopride |
| Placebo | Placebo comparator | <each cohort> Matching Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of adverse events, seriousness of adverse event
Measured: D1~Post study visit
significant changes in vital sign
Measured: D1~Post study visit
significant changes in 12-lead electrocardiography
Measured: D1~Post study visit
significant changes in laboratory test
Measured: D1~Post study visit
significant physical exam
Measured: D1~Post study visit
Secondary outcomes (5)
Cmax
Measured: 0~48 hrs(SAD,FSD cohorts), 0~24 hrs/D5,6 0hr/D7 0~48hrs(MAD cohort)
AUC
Measured: 0~48 hrs(SAD,FSD cohorts), 0~24 hrs/D5,6 0hr/D7 0~48hrs(MAD cohort)
Ae
Measured: 0~48 hrs(SAD cohort), 0~24 hrs/D7 0~48hrs(MAD cohort)
BSFS
pharmacodynamics
Measured: D1~7(SAD, FSD cohorts), D1~14(MAD cohort)
Frequency of defecation
pharmacodynamics
Measured: D1~7(SAD, FSD cohorts), D1~14(MAD cohort)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startAug 2013
- Primary completionApr 2015
- Study completionApr 2015
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870674
- Sponsor's protocol ID
- YH12852-101
- Status last verified
- May 2015
- First submitted
- 20 May 2013
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo/Active-controlled, Single/Multiple Dose Phase 1 Clinical Study to Investigate the Safety/Tolerability and PK/PD of YH12852 After Oral Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01870674
- Acronym / sponsor ID
- YH12852-101
- Conditions
- Healthy
- Keywords
- safety, tolerability, pharmacokinetics, pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 6 Jun 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.
Study to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics(PK/PD)of YH12852 after oral administration in healthy subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| YH12852 | Experimental | Drug: YH12852<SAD cohort> * Experimental: YH12852 1mg/single dose, qd * Experimental: YH12852 3mg/single dose, qd * Experimental: YH12852 10mg/single dose, qd <FSD cohort> * Experimental: YH12852 0.5mg/single dose, qd * Experimental: YH12852 1mg/single dose, qd * Experimental: YH12852 2mg/single dose, qd * Experimental: YH12852 3mg/single dose, qd <MAD cohort> * Experimental: YH12852 0.5mg/repeat dose, qd * Experimental: YH12852 1mg/repeat dose, qd * Experimental: YH12852 2mg/repeat dose, qd * Experimental: YH12852 3mg/repeat dose, qd * Each dosing group(except MAD cohort 0.5mg which has single treatment arm taking YH12852 only) contains 12 subjects. 12 subjects are administered YH12852 or placebo/active comparators.(YH12852:placebo:active=8:2:2) |
| Prucalopride | Active comparator | Drug: Prucalopride<each cohort> Prucalopride succinate 1.321mg |
| Placebo | Placebo comparator | Drug: Placebo<each cohort> Matching Placebo |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy male/female aged 19 to 45 with body mass index(BMI) between 18 and 25kg/m2
- Subject who has no congenital, chronic disease and disease symptoms in medical examination result
- 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, 12-lead ECG etc)
- Subjects 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
Key exclusion criteria (13 listed)
- 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 is hypersensitive to components contained in YH12852 or prucalopride or aspirin/antibiotics like drugs
- Medical history of gastrointestinal disease or acid restraining surgery, gastric/ esophagus surgery(excluding appendectomy, hernia surgery)
- Clinically significant abnormal values in diagnostic check within 28 days before the treatment(>1.25 fold of normal upper limit in the levels of AST or ALT, >1.5 fold of normal upper limit in the levels of Total bilirubin, < 80ml/min of Cockcroft-Gault used creatinine clearance
- Subject has over QTc interval of 550 ms or PR interval of 210 ms or QRS interval of 120 ms or QT interval of 500 ms on baseline 12-lead ECG, as determined by the Investigator
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 |
|---|---|---|
| YH12852 | Drug | YH12852 |
| Prucalopride | Drug | Prucalopride |
| Placebo | Drug | Placebo |
Primary outcome
the number of adverse events, seriousness of adverse event
Time frame: D1~Post study visit
significant changes in vital sign
Time frame: D1~Post study visit
significant changes in 12-lead electrocardiography
Time frame: D1~Post study visit
significant changes in laboratory test
Time frame: D1~Post study visit
significant physical exam
Time frame: D1~Post study visit
5 secondary outcomes
Cmax
Time frame: 0~48 hrs(SAD,FSD cohorts), 0~24 hrs/D5,6 0hr/D7 0~48hrs(MAD cohort)
AUC
Time frame: 0~48 hrs(SAD,FSD cohorts), 0~24 hrs/D5,6 0hr/D7 0~48hrs(MAD cohort)
Ae
Time frame: 0~48 hrs(SAD cohort), 0~24 hrs/D7 0~48hrs(MAD cohort)
BSFS
Time frame: D1~7(SAD, FSD cohorts), D1~14(MAD cohort)
Frequency of defecation
Time frame: D1~7(SAD, FSD cohorts), D1~14(MAD cohort)
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 8 May 2015.
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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 YH12852 and Prucalopride 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 8 May 2015. 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?
the number of adverse events, seriousness of adverse event (time frame: D1~Post study visit). The study lists 5 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 8 May 2015.