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Absolute Bioavailability of YH4808 With Accelerator Mass Spectrometry(AMS)-Based Microdose Study

Primary Purpose

Gastroesophageal Reflux Disease

Status
Completed
Phase
Early Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
YH4808 PO and [14C]-YH4808 IV
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Gastroesophageal Reflux Disease focused on measuring absolute bioavailability,, microdose,, AMS

Eligibility Criteria

20 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy male subject aged 20 to 45 at screening
  • subjects who have weight over 55 kg with BMI ranged from 20.0 to 25.0
  • subjects who decide to participate voluntarily and write a informed consent form

Exclusion Criteria:

  • subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
  • clinically significant allergic disease (except for mild allergic rhinitis)
  • subjects who have determined not eligible by screening test (medical history, physical examination, 12-lead ECG, laboratory test, etc) within 28 days of study start
  • subjects considered unsuitable for inclusion by the investigator

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Microdose

Arm Description

Outcomes

Primary Outcome Measures

Absolute bioavailability (Fpo)

Secondary Outcome Measures

Full Information

First Posted
February 21, 2014
Last Updated
April 17, 2014
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02072447
Brief Title
Absolute Bioavailability of YH4808 With Accelerator Mass Spectrometry(AMS)-Based Microdose Study
Official Title
A Study to Determine the Absolute Bioavailability of YH4808 Using Simultaneous Oral Therapeutic- and [14C]-Labeled Intravenous Microdoses
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

5. Study Description

Brief Summary
This study aims to determine the absolute bioavailability of YH4808 using simultaneous oral therapeutic- and [14C]-labeled intravenous microdoses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
absolute bioavailability,, microdose,, AMS

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Microdose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
YH4808 PO and [14C]-YH4808 IV
Primary Outcome Measure Information:
Title
Absolute bioavailability (Fpo)
Time Frame
predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 13, 24, 48, 96, 144, 216 hours post-dose

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy male subject aged 20 to 45 at screening subjects who have weight over 55 kg with BMI ranged from 20.0 to 25.0 subjects who decide to participate voluntarily and write a informed consent form Exclusion Criteria: subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor clinically significant allergic disease (except for mild allergic rhinitis) subjects who have determined not eligible by screening test (medical history, physical examination, 12-lead ECG, laboratory test, etc) within 28 days of study start subjects considered unsuitable for inclusion by the investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Links:
URL
http://ctc.snuh.org
Description
Webpage of clinical trial center of Seoul National University Hospital

Learn more about this trial

Absolute Bioavailability of YH4808 With Accelerator Mass Spectrometry(AMS)-Based Microdose Study

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