Mass Balance Study of FYU-981

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Male Subjects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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14C-FYU-981

14C-FYU-981, (Oral single dosing)

Group Type EXPERIMENTAL

14C-FYU-981

Intervention Type DRUG

14C-FYU-981, (Oral single dosing)

Interventions

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14C-FYU-981

14C-FYU-981, (Oral single dosing)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes