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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation
ClinicalTrials.gov Identifier:
NCT01007019
First received: November 2, 2009
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

First in human study


Condition Intervention Phase
Healthy
Drug: YH4808 30mg
Drug: YH4808 50mg
Drug: YH4808 100mg
Drug: YH4808 200mg
Drug: YH4808
Drug: YH4808 100mg (repeat dose)
Drug: YH4808 200mg (repeat dose)
Drug: YH4808 600mg
Drug: YH4808 800mg (single dose)
Drug: YH4808 400 mg (repeat doses)
Drug: Placebo
Drug: Esomeprazole 40mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Yuhan Corporation:

Primary Outcome Measures:
  • To evaluate the PKs, PDs, safety and tolerability of escalating, single/multiple oral doses of YH4808 [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Enrollment: 134
Study Start Date: November 2009
Study Completion Date: March 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: YH4808 30mg

1.Single dose

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

Drug: YH4808 30mg
YH4808 30mg (single dose)
Other Name: YH4808 30mg (single dose)
Experimental: YH4808 50mg

1.Single dose

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

Drug: YH4808 50mg
YH4808 50mg (single dose)
Other Name: YH4808 50mg (single dose)
Experimental: YH4808 100mg

1.Single dose

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

Drug: YH4808 100mg
YH4808 100mg (single dose)
Other Name: YH4808 100mg (single dose)
Experimental: YH4808 200mg

1.Single dose

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

Drug: YH4808 200mg
YH4808 200mg (single dose)
Other Name: YH4808 200mg (single dose)
Experimental: YH4808 400mg

1.Single dose

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

Drug: YH4808
YH4808 400mg (single dose)
Other Name: YH4808 400mg (single dose)
Experimental: YH4808 100mg(repeat doses)

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 100mg (repeat dose)
Other Name: YH4808 100mg (repeat dose)
Experimental: YH4808 200mg(repeat doses)

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 200mg (repeat dose)
Other Name: YH4808 200mg (repeat dose)
Experimental: YH4808 400mg(repeat doses)

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 400 mg (repeat doses)
Other Name: YH4808 400 mg (repeat doses)
Experimental: YH4808 600mg

1.Single dose

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

Drug: YH4808 600mg
YH4808 600mg
Other Name: YH4808 600mg
Experimental: YH4808 800mg

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)
YH4808 800mg (single dose)
Other Name: YH4808 800mg (single dose)
Placebo Comparator: Placebo Drug: Placebo
10 volunteers will be administered matched placebo.
Other Name: 10 volunteers will be administered matched placebo.
Active Comparator: Esomeprazole 40mg Drug: Esomeprazole 40mg
24 volunteers will be administered Esomeprazole 40mg
Other Name: 24 volunteers will be administered Esomeprazole 40mg

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.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01007019

Locations
Korea, Republic of
Clinical trials center, Seoul national university hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Yuhan Corporation
Investigators
Principal Investigator: Kyung-Sang Yu, MD, PhD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01007019     History of Changes
Other Study ID Numbers: YCD142 (YH4808-101)
Study First Received: November 2, 2009
Last Updated: July 8, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Yuhan Corporation:
Safety, tolerability and PK/PD

Additional relevant MeSH terms:
Esomeprazole
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014