Healthy
Conditions
Keywords
safety, tolerability, pharmacokinetics, pharmacodynamics
Brief summary
Study to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics(PK/PD)of YH12852 after oral administration in healthy subjects
Interventions
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| significant physical exam | D1~Post study visit |
| the number of adverse events, seriousness of adverse event | D1~Post study visit |
| significant changes in vital sign | D1~Post study visit |
| significant changes in 12-lead electrocardiography | D1~Post study visit |
| significant changes in laboratory test | D1~Post study visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 0~48 hrs(SAD,FSD cohorts), 0~24 hrs/D5,6 0hr/D7 0~48hrs(MAD cohort) | — |
| AUC | 0~48 hrs(SAD,FSD cohorts), 0~24 hrs/D5,6 0hr/D7 0~48hrs(MAD cohort) | — |
| Ae | 0~48 hrs(SAD cohort), 0~24 hrs/D7 0~48hrs(MAD cohort) | — |
| BSFS | D1~7(SAD, FSD cohorts), D1~14(MAD cohort) | pharmacodynamics |
| Frequency of defecation | D1~7(SAD, FSD cohorts), D1~14(MAD cohort) | pharmacodynamics |
Countries
South Korea
Outcome results
None listed