Healthy
Conditions
Keywords
Safety, tolerability and PK/PD
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.
Interventions
DRUGEsomeprazole 40mg
24 volunteers will be administered Esomeprazole 40mg
DRUGYH4808 30mg
YH4808 30mg (single dose)
DRUGYH4808 50mg
YH4808 50mg (single dose)
DRUGYH4808 100mg
YH4808 100mg (single dose)
DRUGYH4808 200mg
YH4808 200mg (single dose)
DRUGYH4808
YH4808 400mg (single dose)
DRUGYH4808 100mg (repeat dose)
YH4808 100mg (repeat dose)
DRUGYH4808 200mg (repeat dose)
YH4808 200mg (repeat dose)
DRUGYH4808 600mg
YH4808 600mg
DRUGYH4808 800mg (single dose)
YH4808 800mg (single dose)
DRUGYH4808 400 mg (repeat doses)
YH4808 400 mg (repeat doses)
DRUGPlacebo
10 volunteers will be administered matched placebo.
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the PKs, PDs, safety and tolerability of escalating, single/multiple oral doses of YH4808 | Throughout the study |
Countries
South Korea
Outcome results
None listed