Completed

A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-YH4808 Following Single Oral Dose Administration in Healthy Male Subjects

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

[14C]-YH4808 200 mg

Drug
Who is being recruted

From 18 to 55 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Phase 1
Interventional
Study Start: January 2013
See protocol details

Summary

Principal SponsorYuhan Corporation
Last updated: July 14, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to Study Entry (ie, prior to Check-in [Day -1]). Subjects will be confined at the Clinical Research Unit (CRU) from Check in (Day -1) until Discharge Criteria have been met (as early as Day 6 and as late as Day 11). In this study design, physical examinations, electrocardiograms (ECGs), vital signs, How do you feel? (HDYF?) Inquiries, and clinical laboratory evaluations will be performed at Screening, at specified times during the study, and/or at Clinic Discharge. All AEs, whether volunteered, elicited, or noted on physical examination, will be recorded throughout the study (ie, from dosing on Day 1 until Clinic Discharge [Day 11]).

NCT01825707
Principal SponsorYuhan Corporation
Last updated: July 14, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

8 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate
able to comprehend and willing to sign an Informed Consent Form
clinical laboratory evaluations within the reference range for the test laboratory
negative test for selected drugs of abuse, hepatitis panel and HIV antibody screens
4 exclusion criteria prevent from participating
donation of blood from 30 days prior to Screening through Study Completion, inclusive, or of plasma from 2 weeks prior to Screening through Study Completion, inclusive
history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
participation in more than 1 other radiolabeled investigational study drug trial within 12 months prior to Check-in
significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
[14C]-YH4808 200 mg

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Covance Clinical Research Unit

Madison, United StatesOpen Covance Clinical Research Unit in Google Maps
CompletedOne Study Center