NCT01007019

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Yuhan Corporation · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-03-01
• Completion: 2012-03-01
• First posted: 2009-11-03
• Last updated: 2014-07-10

Locations

1 site across 1 country: South Korea