NCT01007019

Brief Summary

First in human study

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Nov 2009

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

July 10, 2014

Status Verified

July 1, 2014

Enrollment Period

1.3 years

First QC Date

November 2, 2009

Last Update Submit

July 8, 2014

Conditions

Healthy

Keywords

Safety, tolerability and PK/PD

Outcome Measures

Primary Outcomes (1)

  • To evaluate the PKs, PDs, safety and tolerability of escalating, single/multiple oral doses of YH4808

    Throughout the study

Study Arms (12)

YH4808 30mg

EXPERIMENTAL

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

Drug: YH4808 30mg

YH4808 50mg

EXPERIMENTAL

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

Drug: YH4808 50mg

YH4808 100mg

EXPERIMENTAL

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

Drug: YH4808 100mg

YH4808 200mg

EXPERIMENTAL

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

Drug: YH4808 200mg

YH4808 400mg

EXPERIMENTAL

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

Drug: YH4808

YH4808 100mg(repeat doses)

EXPERIMENTAL

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)

YH4808 200mg(repeat doses)

EXPERIMENTAL

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)

YH4808 400mg(repeat doses)

EXPERIMENTAL

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)

YH4808 600mg

EXPERIMENTAL

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

Drug: YH4808 600mg

YH4808 800mg

EXPERIMENTAL

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)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Esomeprazole 40mg

ACTIVE COMPARATOR
Drug: Esomeprazole 40mg

Interventions

YH4808 30mgDRUG

YH4808 30mg (single dose)

Also known as: YH4808 30mg (single dose)
YH4808 30mg
YH4808 50mgDRUG

YH4808 50mg (single dose)

Also known as: YH4808 50mg (single dose)
YH4808 50mg
YH4808 100mgDRUG

YH4808 100mg (single dose)

Also known as: YH4808 100mg (single dose)
YH4808 100mg
YH4808 200mgDRUG

YH4808 200mg (single dose)

Also known as: YH4808 200mg (single dose)
YH4808 200mg
YH4808DRUG

YH4808 400mg (single dose)

Also known as: YH4808 400mg (single dose)
YH4808 400mg
YH4808 100mg (repeat dose)DRUG

YH4808 100mg (repeat dose)

YH4808 100mg(repeat doses)
YH4808 200mg (repeat dose)DRUG

YH4808 200mg (repeat dose)

YH4808 200mg(repeat doses)
YH4808 600mgDRUG

YH4808 600mg

YH4808 600mg
YH4808 800mg (single dose)DRUG

YH4808 800mg (single dose)

YH4808 800mg
YH4808 400 mg (repeat doses)DRUG

YH4808 400 mg (repeat doses)

YH4808 400mg(repeat doses)
PlaceboDRUG

10 volunteers will be administered matched placebo.

Also known as: 10 volunteers will be administered matched placebo.
Placebo
Esomeprazole 40mgDRUG

24 volunteers will be administered Esomeprazole 40mg

Also known as: 24 volunteers will be administered Esomeprazole 40mg
Esomeprazole 40mg

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical trials center, Seoul national university hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Interventions

YH4808Esomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Kyung-Sang Yu, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2009

First Posted

November 3, 2009

Study Start

November 1, 2009

Primary Completion

March 1, 2011

Study Completion

March 1, 2012

Last Updated

July 10, 2014

Record last verified: 2014-07

Locations

KR(1)