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

NCT01870674 | Completed Phase 1 DMC

• 1 other identifier: YH12852-101
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

safety; tolerability; pharmacokinetics; pharmacodynamics

Outcome Measures

Primary Outcomes (5)

• 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

• significant physical exam

  D1~Post study visit

Secondary Outcomes (5)

• Cmax

  0~48 hrs(SAD,FSD cohorts), 0~24 hrs/D5,6 0hr/D7 0~48hrs(MAD cohort)

• AUC

  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)

• BSFS

  D1~7(SAD, FSD cohorts), D1~14(MAD cohort)

• Frequency of defecation

  D1~7(SAD, FSD cohorts), D1~14(MAD cohort)

Study Arms (3)

YH12852

EXPERIMENTAL

\<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)

Drug: YH12852

Prucalopride

ACTIVE COMPARATOR

\<each cohort\> Prucalopride succinate 1.321mg

Drug: Prucalopride

Placebo

PLACEBO COMPARATOR

\<each cohort\> Matching Placebo

Drug: Placebo

Interventions

YH12852 DRUG

YH12852

Prucalopride DRUG

Prucalopride

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (1)

Inje Busan Paik hospital

Busan, 614-735, South Korea

Location

MeSH Terms

Interventions

YH12852; prucalopride

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2013
• First Posted: June 6, 2013
• Study Start: August 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 8, 2015

Record last verified: 2015-05

Locations

KR (1)