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

Yuhan

Status and phase: Completed; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01007019

YCD142 (YH4808-101)

Details and patient eligibility

About

First in human study

Full 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.

Enrollment: 134 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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134 participants in 12 patient groups, including a placebo group

YH4808 30mg

Experimental group

Description:

1.Single dose 2.12 volunteers were administered YH4808 30mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)

Treatment:

Drug: YH4808 30mg

YH4808 50mg

Experimental group

Description:

1.Single dose 2.12 volunteers were administered YH4808 50mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)

Treatment:

Drug: YH4808 50mg

YH4808 100mg

Experimental group

Description:

1.Single dose 2.12 volunteers were administered YH4808 100mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)

Treatment:

Drug: YH4808 100mg

YH4808 200mg

Experimental group

Description:

1.Single dose 2.12 volunteers were administered YH4808 200mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)

Treatment:

Drug: YH4808 200mg

YH4808 400mg

Experimental group

Description:

1.Single dose 2.12 volunteers were administered YH4808 400mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)

Treatment:

Drug: YH4808

YH4808 100mg(repeat doses)

Experimental group

Description:

1.Repeat doses 2.12 volunteers were administered YH4808 100mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)

Treatment:

Drug: YH4808 100mg (repeat dose)

YH4808 200mg(repeat doses)

Experimental group

Description:

1.Repeat doses 2.16 volunteers were administered YH4808 200mg or active/placebo comparators.(YH4808:active:placebo=8:6:2)

Treatment:

Drug: YH4808 200mg (repeat dose)

YH4808 400mg(repeat doses)

Experimental group

Description:

1.Repeat dose 2.12 volunteers were administered YH4808 400mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)

Treatment:

Drug: YH4808 400 mg (repeat doses)

YH4808 600mg

Experimental group

Description:

1.Single dose 2.12 volunteers were administered YH4808 600mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)

Treatment:

Drug: YH4808 600mg

YH4808 800mg

Experimental group

Description:

1.Single dose 2.12 volunteers were administered YH4808 800mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)

Treatment:

Drug: YH4808 800mg (single dose)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Esomeprazole 40mg

Active Comparator group

Treatment:

Drug: Esomeprazole 40mg