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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: YH12852; Drug: Prucalopride

• 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

Study Timeline

• Study First Submitted: 2013-05-20
• Study First Submitted QC: 2013-06-03
• Study First Posted: 2013-06-06
• Study Start: 2013-08
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-07
• Last Update Posted: 2015-05-08

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
the number of adverse events, seriousness of adverse event	D1~Post study visit
significant changes in vital sign	D1~Post study visit
significant physical exam	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