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

Study Overview
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Brief Summary
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First in human study

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

Official Title
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A Dose-block Randomized, Double-blind, Placebo/Active-controlled, Single/Multiple Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety/Tolerability and PKs/PDs of YH4808 After Oral Administration in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: YH4808 30mg
* Drug: YH4808 50mg
* Drug: YH4808 100mg
* Drug: YH4808 200mg
* Drug: YH4808
* Drug: YH4808 100mg (repeat dose)
* Drug: YH4808 200mg (repeat dose)
* Drug: YH4808 600mg
* Drug: YH4808 800mg (single dose)
* Drug: YH4808 400 mg (repeat doses)
* Drug: Placebo
* Drug: Esomeprazole 40mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YH4808 30mg<br>1.Single dose 2.12 volunteers were administered YH4808 30mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) | Drug: YH4808 30mg<br>* YH4808 30mg (single dose)<br>* Other names: YH4808 30mg (single dose);|
| Experimental: YH4808 50mg<br>1.Single dose 2.12 volunteers were administered YH4808 50mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) | Drug: YH4808 50mg<br>* YH4808 50mg (single dose)<br>* Other names: YH4808 50mg (single dose);|
| Experimental: YH4808 100mg<br>1.Single dose 2.12 volunteers were administered YH4808 100mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) | Drug: YH4808 100mg<br>* YH4808 100mg (single dose)<br>* Other names: YH4808 100mg (single dose);|
| Experimental: YH4808 200mg<br>1.Single dose 2.12 volunteers were administered YH4808 200mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) | Drug: YH4808 200mg<br>* YH4808 200mg (single dose)<br>* Other names: YH4808 200mg (single dose);|
| Experimental: YH4808 400mg<br>1.Single dose 2.12 volunteers were administered YH4808 400mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) | Drug: YH4808<br>* YH4808 400mg (single dose)<br>* Other names: YH4808 400mg (single dose);|
| Experimental: YH4808 100mg(repeat doses)<br>1.Repeat doses 2.12 volunteers were administered YH4808 100mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) | Drug: YH4808 100mg (repeat dose)<br>* YH4808 100mg (repeat dose)<br>|
| Experimental: YH4808 200mg(repeat doses)<br>1.Repeat doses 2.16 volunteers were administered YH4808 200mg or active/placebo comparators.(YH4808:active:placebo=8:6:2) | Drug: YH4808 200mg (repeat dose)<br>* YH4808 200mg (repeat dose)<br>|
| Experimental: YH4808 400mg(repeat doses)<br>1.Repeat dose 2.12 volunteers were administered YH4808 400mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) | Drug: YH4808 400 mg (repeat doses)<br>* YH4808 400 mg (repeat doses)<br>|
| Experimental: YH4808 600mg<br>1.Single dose 2.12 volunteers were administered YH4808 600mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) | Drug: YH4808 600mg<br>* YH4808 600mg<br>|
| Experimental: YH4808 800mg<br>1.Single dose 2.12 volunteers were administered YH4808 800mg or active/placebo comparators.(YH4808:active:placebo=8:2:2) | Drug: YH4808 800mg (single dose)<br>* YH4808 800mg (single dose)<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 10 volunteers will be administered matched placebo.<br>* Other names: 10 volunteers will be administered matched placebo.;|
| Active Comparator: Esomeprazole 40mg<br> | Drug: Esomeprazole 40mg<br>* 24 volunteers will be administered Esomeprazole 40mg<br>* Other names: 24 volunteers will be administered Esomeprazole 40mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the PKs, PDs, safety and tolerability of escalating, single/multiple oral doses of YH4808 |  | Throughout the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, tolerability and PK/PD