Mass Balance Study of FYU-981

August 20, 2018 updated by: Fuji Yakuhin Co., Ltd.

Plasma Concentration, Excretion and Mass Balance Orally Administered 14C-FYU-981 in Healthy Male Subjects

To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites of FYU-981 after a single 1 mg oral dose of 14C-FYU-981 in healthy male subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 31 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Japanese healthy adult subjects
  • Body mass index: >=18.5 and <25.0

Exclusion Criteria:

  • Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study
  • Have participated in a [14C]-study within the last 12 months prior to dosing of the investigational drug
  • Exposure to radiation for therapeutic or diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton) within the last 12 months prior to dosing of the investigational drug
  • Occupationally exposed worker

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 14C-FYU-981
14C-FYU-981, (Oral single dosing)
Drug: 14C-FYU-981
14C-FYU-981, (Oral single dosing)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (Cmax: Maximum plasma concentration)
Time Frame: 168 hours
168 hours
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
Time Frame: 168 hours
168 hours
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
Time Frame: 168 hours
168 hours
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
Time Frame: 168 hours
168 hours
Pharmacokinetics (kel: Elimination rate constant)
Time Frame: 168 hours
168 hours
Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed
Time Frame: 168 hours
168 hours
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
Time Frame: 168 hours
168 hours
Pharmacokinetics (MRT: Mean residence time)
Time Frame: 168 hours
168 hours
Pharmacokinetics (Ae(urine), Ae(feces) and Ae(air): Amount of radioactivity excreted in urine, feces, or air)
Time Frame: 168 hours or 72 hours (Ae(air))
168 hours or 72 hours (Ae(air))
Pharmacokinetics (fe(urine) , fe(feces) and fe(air): Fraction of radioactivity excreted in urine, feces, or air)
Time Frame: 168 hours or 72 hours (Ae(air))
168 hours or 72 hours (Ae(air))
Pharmacokinetics (Ae(total): Total amount of radioactivity excreted)
Time Frame: 168 hours
168 hours
Pharmacokinetics (fe(total): Total fraction of radioactivity excreted)
Time Frame: 168 hours
168 hours
Pharmacokinetics (Ae(urine + air): Amount of radioactivity excreted in urine and air)
Time Frame: 168 hours
168 hours
Pharmacokinetics (fe(urine + air): Fraction of radioactivity excreted in urine and air)
Time Frame: 168 hours
168 hours
Pharmacokinetics (Ratios of FYU-981 and its metabolites in plasma, urine and feces)
Time Frame: 168 hours
168 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fuji Yakuhin Co., Ltd.

Collaborators

Mochida Pharmaceutical Company, Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

September 12, 2016

First Submitted That Met QC Criteria

September 12, 2016

First Posted (Estimate)

September 15, 2016

Study Record Updates

Last Update Posted (Actual)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FYU-981-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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