HealthyPhase 1NCT01825707
AME Study of [14C]-YH4808 in Healthy Male Subjects
A Phase 1 study testing [14C]-YH4808 200 mg in people with Healthy, run by Yuhan Corporation at 1 site in United States.
Trial summary
The purpose of this study is to determine the absorption, metabolism, and excretion (AME) kinetics of YH4808 and to determine and characterize metabolites present in plasma, urine, and feces in man following a single dose of [14C] YH4808 200 mg (~100 µCi ±20 µCi) administered as a single oral dose. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [14C]-YH4808 200 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Mar 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- clinical laboratory evaluations within the reference range for the test laboratory
- negative test for selected drugs of abuse, hepatitis panel and HIV antibody screens
- able to comprehend and willing to sign an Informed Consent Form
Who cannot join
- significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
- 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
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit
Madison, Wisconsin, 53704
About this study
Official title: A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-YH4808 Following Single Oral Dose Administration in Healthy Male Subjects
The purpose of this study is to determine the absorption, metabolism, and excretion (AME) kinetics of YH4808 and to determine and characterize metabolites present in plasma, urine, and feces in man following a single dose of [14C] YH4808 200 mg (~100 µCi ±20 µCi) administered as a single oral dose.
Read the detailed description
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]).
- Conditions
- Healthy
- Being tested
- [14C]-YH4808 200 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-YH4808 200 mgDrug
Also called YH4808 200 mg (100 µCi)
[14C]-YH4808 200 mg (oral) on day1
| Study group | Role | What they receive |
|---|---|---|
| [14C]-YH4808 200 mg | Experimental | [14C]-YH4808 200 mg Receives: Drug: [14C]-YH4808 200 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK of a single oral dose of [14C] YH4808 200 mg and its metabolites(M3, M8)
- Maximum observed concentration in plasma, whole blood, urine, and feces
- Time to maximum observed concentration in plasma, whole blood, urine, and feces
- Area under the concentration-time curve from Hour 0 to the last measurable concentration
- Assessment of Mass balance
Measured: Day1-Day11
Secondary outcomes (2)
Characterization and identification of metabolites of [14C]-YH4808 in plasma, urine, and feces
Measured: Day1-Day11
assessment of the safety and tolerability of YH4808
- Clinical laboratory tests
- 12-lead ECGs
- Physical examinations
- Vital signs
- Adverse event assessments
Measured: Day1-Day11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicholas Siebers, M.D., Principal investigator, Covance Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825707
- Sponsor's protocol ID
- YH4808-103
- Status last verified
- Jul 2014
- First submitted
- 14 Mar 2013
- Last updated
- 14 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-YH4808 Following Single Oral Dose Administration in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01825707
- Acronym / sponsor ID
- YH4808-103
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 8 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the absorption, metabolism, and excretion (AME) kinetics of YH4808 and to determine and characterize metabolites present in plasma, urine, and feces in man following a single dose of [14C] YH4808 200 mg (~100 µCi ±20 µCi) administered as a single oral dose.
Detailed description
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]).
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-YH4808 200 mg | Experimental | Drug: [14C]-YH4808 200 mg[14C]-YH4808 200 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- clinical laboratory evaluations within the reference range for the test laboratory
- negative test for selected drugs of abuse, hepatitis panel and HIV antibody screens
- able to comprehend and willing to sign an Informed Consent Form
Key exclusion criteria (4 listed)
- significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]-YH4808 200 mgAlso: YH4808 200 mg (100 µCi)[14C]-YH4808 200 mg (oral) on day1 | Drug | [14C]-YH4808 200 mg |
Primary outcome
PK of a single oral dose of [14C] YH4808 200 mg and its metabolites(M3, M8)
Time frame: Day1-Day11
* Maximum observed concentration in plasma, whole blood, urine, and feces * Time to maximum observed concentration in plasma, whole blood, urine, and feces * Area under the concentration-time curve from Hour 0 to the last measurable concentration * Assessment of Mass balance
2 secondary outcomes
Characterization and identification of metabolites of [14C]-YH4808 in plasma, urine, and feces
Time frame: Day1-Day11
assessment of the safety and tolerability of YH4808
Time frame: Day1-Day11
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Siebers, M.D. principal investigator
Covance Clinical Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]-YH4808 200 mg in people with Healthy, run by Yuhan Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK of a single oral dose of [14C] YH4808 200 mg and its metabolites(M3, M8) (time frame: Day1-Day11). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2014.