Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of YH12852 After Oral Administration in Healthy Male Subjects
- Registration Number
- NCT01870674
- Lead Sponsor
- Yuhan Corporation
- Brief Summary
Study to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics(PK/PD)of YH12852 after oral administration in healthy subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 127
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo \<each cohort\> Matching Placebo YH12852 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 Prucalopride \<each cohort\> Prucalopride succinate 1.321mg
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method AUC 0~48 hrs(SAD,FSD cohorts), 0~24 hrs/D5,6 0hr/D7 0~48hrs(MAD cohort) BSFS D1~7(SAD, FSD cohorts), D1~14(MAD cohort) pharmacodynamics
Cmax 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) Frequency of defecation D1~7(SAD, FSD cohorts), D1~14(MAD cohort) pharmacodynamics
Trial Locations
- Locations (1)
Inje Busan Paik hospital
🇰🇷Busan, Korea, Republic of