NCT02072447

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Mar 2014

Shorter than P25 for early_phase_1

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

February 21, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 26, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 21, 2014

Status Verified

April 1, 2014

Enrollment Period

1 month

First QC Date

February 21, 2014

Last Update Submit

April 17, 2014

Conditions

Gastroesophageal Reflux Disease

Keywords

absolute bioavailability,microdose,AMS

Outcome Measures

Primary Outcomes (1)

  • Absolute bioavailability (Fpo)

    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

Study Arms (1)

Microdose

EXPERIMENTAL
Drug: YH4808 PO and [14C]-YH4808 IV

Interventions

YH4808 PO and [14C]-YH4808 IVDRUG
Microdose

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Links

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 21, 2014

First Posted

February 26, 2014

Study Start

March 1, 2014

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 21, 2014

Record last verified: 2014-04

Locations

KR(1)