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

NCT ID: NCT01870674

Last Updated: 2015-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-04-30

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

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)

Group Type: EXPERIMENTAL

YH12852

Intervention Type: DRUG

Prucalopride

\<each cohort\> Prucalopride succinate 1.321mg

Group Type: ACTIVE_COMPARATOR

Prucalopride

Intervention Type: DRUG

Placebo

\<each cohort\> Matching Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

YH12852

Intervention Type: DRUG

Prucalopride

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yuhan Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Inje Busan Paik hospital

Busan, , South Korea

Countries

South Korea

Other Identifiers

YH12852-101

Identifier Type: -

Identifier Source: org_study_id