Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of YH12852 After Oral Administration in Healthy Male Subjects

Yuhan

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: YH12852

Drug: Prucalopride

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01870674

YH12852-101

Details and patient eligibility

About

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

Enrollment

127 patients

Sex

All

Ages

19 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

127 participants in 3 patient groups, including a placebo group

YH12852

Experimental group

Description:

\<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)

Treatment:

Drug: YH12852

Prucalopride

Active Comparator group

Description:

\<each cohort\> Prucalopride succinate 1.321mg

Treatment:

Drug: Prucalopride

Placebo

Placebo Comparator group

Description:

\<each cohort\> Matching Placebo