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: March 29, 2012
Last verified: January 2012
  Purpose

Study to evaluate the safety and tolerability, pharmacokinetics/pharmacodynamics (PK/PD) parameters of an escalating, single dose/repeat doses of YH4808 in healthy subjects.


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

  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
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: March 29, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

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

ClinicalTrials.gov processed this record on April 17, 2014