Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of YH4808 After Oral Administration in Healthy Male Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: YH4808 400 mg (repeat doses); Drug: YH4808 600mg; Drug: Esomeprazole 40mg; Drug: YH4808 50mg; Drug: Placebo; Drug: YH4808 30mg; Drug: YH4808 200mg (repeat dose); Drug: YH4808 100mg; Drug: YH4808 200mg; Drug: YH4808 100mg (repeat dose); Drug: YH4808 800mg (single dose); Drug: YH4808

• Registration Number: NCT01007019
• Lead Sponsor: Yuhan Corporation

Brief Summary

First in human study

Detailed Description

Study to evaluate the safety and tolerability, pharmacokinetics/pharmacodynamics (PK/PD) parameters of an escalating, single dose/repeat doses of YH4808 in healthy subjects.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-02
• Study First Submitted QC: 2009-11-02
• Study First Posted: 2009-11-03
• Primary Completion: 2011-03
• Study Completion: 2012-03
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-08
• Last Update Posted: 2014-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 134

Inclusion Criteria

• Healthy male volunteers in the age between 20 to 45 years old
• Subjects who were determined to be appropriate through screening
• Weight: over 50kg, within ±20% of ideal body weight
• Subjects who signed written consent after receiving thorough explanation on trial purpose, content, and characteristics of investigational drug

Exclusion Criteria

• Clinically significant disorder in liver, kidney, cardiovascular, respiratory system, endocrine system and CNS in the physical examination and clinical laboratory tests or a medical history of malignant tumor or psychological disease
• Medical history of gastrointestinal disease or acid restraining surgery, gastric/esophagus surgery (excluding appendectomy, hernia surgery)
• A history of hypersensitivity to drugs or clinically significant allergic disease
• Clinically significant abnormal values in blood chemistry(≥ 1.5 fold of normal upper limit in the levels of SGOT, SGPT)
• Subjects who were unable to be applicable for pH meter catheter
• Subjects who had a history of drug abuse or who had a positive results on urine drug screening
• Subjects 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(cf, be able to be enrolled in this study according to an investigatory consideration)
• Subjects who participated in another clinical trial within 3 months before enrolling in this study
• Subjects who donated whole blood within 2 months or component blood within 1 month or who are donated within 1 month before the treatment
• Subjects who drank Over 21 units/week of alcohol or subjects who weren't able to stop drinking alcohol during the hospitalization
• Subjects who stopped smoking within 3 months before the treatment
• Subjects who had a beverage containing grapefruits within 24hrs before the hospitalization or who had a beverage containing grapefruits during the hospitalization
• Subjects who had a beverage containing caffeine during the hospitalization
• H.pylori positive results on the Urease breath test(Only repeat doses)
• 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
YH4808 400mg(repeat doses)	YH4808 400 mg (repeat doses)	1.Repeat dose 2.12 volunteers were administered YH4808 400mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)
YH4808 600mg	YH4808 600mg	1.Single dose 2.12 volunteers were administered YH4808 600mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)
Esomeprazole 40mg	Esomeprazole 40mg	-
YH4808 50mg	YH4808 50mg	1.Single dose 2.12 volunteers were administered YH4808 50mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)
Placebo	Placebo	-
YH4808 30mg	YH4808 30mg	1.Single dose 2.12 volunteers were administered YH4808 30mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)
YH4808 200mg(repeat doses)	YH4808 200mg (repeat dose)	1.Repeat doses 2.16 volunteers were administered YH4808 200mg or active/placebo comparators.(YH4808:active:placebo=8:6:2)
YH4808 100mg	YH4808 100mg	1.Single dose 2.12 volunteers were administered YH4808 100mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)
YH4808 200mg	YH4808 200mg	1.Single dose 2.12 volunteers were administered YH4808 200mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)
YH4808 100mg(repeat doses)	YH4808 100mg (repeat dose)	1.Repeat doses 2.12 volunteers were administered YH4808 100mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)
YH4808 800mg	YH4808 800mg (single dose)	1.Single dose 2.12 volunteers were administered YH4808 800mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)
YH4808 400mg	YH4808	1.Single dose 2.12 volunteers were administered YH4808 400mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)

Primary Outcome Measures

Name	Time	Method
To evaluate the PKs, PDs, safety and tolerability of escalating, single/multiple oral doses of YH4808	Throughout the study

Trial Locations

Locations (1)

Clinical trials center, Seoul national university hospital; 🇰🇷 Seoul, Korea, Republic of