NCT01520012

Brief Summary

The main objective is to evaluate the food effect on the pharmacokinetic profile of YH4808 100 mg b.i.d and YH4808 300 mg after oral administration in healthy male subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Feb 2012

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

First Submitted

Initial submission to the registry

January 13, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 27, 2012

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 24, 2012

Status Verified

May 1, 2012

Enrollment Period

3 months

First QC Date

January 13, 2012

Last Update Submit

July 23, 2012

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Area under the plasma concentration versus time curve of YH4808

    non-compartmental analysis

    Blood sampling during 24 or 48 hrs after administration

  • Peak plasma concentration of YH4808

    non-compartmental analysis

    Blood sampling during 24 or 48 hrs after administration

Secondary Outcomes (1)

  • Time to reach peak plasma concentration of YH4808

    Blood sampling during 24 or 48 hrs after administration

Study Arms (5)

Sequence 1

EXPERIMENTAL
Drug: YH4808 100 mg

Sequence 2

EXPERIMENTAL
Drug: YH4808 100 mg

Sequence 3

EXPERIMENTAL
Drug: YH4808 300 mg

Sequence 4

EXPERIMENTAL
Drug: YH4808 300 mg

Sequence 5

EXPERIMENTAL
Drug: YH4808 300 mg

Interventions

YH4808 100 mgDRUG

Period1: YH4808 100 mg bid fasting condition for 7days Period2: YH4808 100 mg bid fed condition for 7days

Sequence 1
YH4808 300 mgDRUG

Period1: YH4808 300 mg fasting condition Period2: YH4808 300 mg fed condition(standard meal) Period3: YH4808 300 mg fed condition(high fat meal)

Sequence 3

Eligibility Criteria

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

You may qualify if:

  • Subjects who signed written consent after receiving thorough explanation on trial purpose, content, and characteristics of investigational drug
  • Healthy male volunteers in the age between 20 to 45 years old
  • Weight: over 50kg, within ±20% of ideal body weight
  • Subjects who were determined to be appropriate through screening

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 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 2 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 were unable 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
  • 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)

Yuhan Corporation

Seoul, 156-754, South Korea

Location

Related Publications (1)

  • Kim E, Kim A, Yi S, Kim YK, Jang SB, Byun HM, Yoon SH, Cho JY, Jang IJ, Yu KS, Lee S. Effect of food on the pharmacokinetics of YH4808, a potassium-competitive acid blocker, after single- and multiple-oral dosing in healthy subjects. Eur J Clin Pharmacol. 2018 Oct;74(10):1261-1272. doi: 10.1007/s00228-018-2502-9. Epub 2018 Jun 15.

    PMID: 29907887DERIVED

MeSH Terms

Interventions

YH4808

Study Officials

  • Kyung-Sang Yu, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2012

First Posted

January 27, 2012

Study Start

February 1, 2012

Primary Completion

May 1, 2012

Study Completion

June 1, 2012

Last Updated

July 24, 2012

Record last verified: 2012-05

Locations

KR(1)