Clinical trial NCT01870674: Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of YH12852 After Oral Administration in Healthy Male Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: safety
tolerability
pharmacokinetics
pharmacodynamics
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2013-06-06
Enrollment: 127
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Study to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics(PK/PD)of YH12852 after oral administration in healthy subjects


Eligibility criteria: 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

Primary outcomes:
measure: the number of adverse events, seriousness of adverse event
timeFrame: D1~Post study visit
measure: significant changes in vital sign
timeFrame: D1~Post study visit
measure: significant changes in 12-lead electrocardiography
timeFrame: D1~Post study visit
measure: significant changes in laboratory test
timeFrame: D1~Post study visit
measure: significant physical exam
timeFrame: D1~Post study visit
Secondary outcomes:
measure: Cmax
timeFrame: 0~48 hrs(SAD,FSD cohorts), 0~24 hrs/D5,6 0hr/D7 0~48hrs(MAD cohort)
measure: AUC
timeFrame: 0~48 hrs(SAD,FSD cohorts), 0~24 hrs/D5,6 0hr/D7 0~48hrs(MAD cohort)
measure: Ae
timeFrame: 0~48 hrs(SAD cohort), 0~24 hrs/D7 0~48hrs(MAD cohort)
measure: BSFS
timeFrame: D1~7(SAD, FSD cohorts), D1~14(MAD cohort)
measure: Frequency of defecation
timeFrame: D1~7(SAD, FSD cohorts), D1~14(MAD cohort)
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje Busan Paik hospital
Study officials:
References: