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

NCT01007019 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2014-07-10

No results posted yet for this study

Summary

First in human study

Conditions

  • Healthy

Interventions

DRUG

YH4808 30mg

YH4808 30mg (single dose)

DRUG

YH4808 50mg

YH4808 50mg (single dose)

DRUG

YH4808 100mg

YH4808 100mg (single dose)

DRUG

YH4808 200mg

YH4808 200mg (single dose)

DRUG

YH4808

YH4808 400mg (single dose)

DRUG

YH4808 100mg (repeat dose)

YH4808 100mg (repeat dose)

DRUG

YH4808 200mg (repeat dose)

YH4808 200mg (repeat dose)

DRUG

YH4808 600mg

YH4808 600mg

DRUG

YH4808 800mg (single dose)

YH4808 800mg (single dose)

DRUG

YH4808 400 mg (repeat doses)

YH4808 400 mg (repeat doses)

DRUG

Placebo

10 volunteers will be administered matched placebo.

DRUG

Esomeprazole 40mg

24 volunteers will be administered Esomeprazole 40mg

Sponsors & Collaborators

  • Yuhan Corporation

    lead INDUSTRY

Principal Investigators

  • Kyung-Sang Yu, MD, PhD · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-03-31
Completion
2012-03-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01007019 on ClinicalTrials.gov