Mass Balance Study of FYU-981

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Healthy Male Subjects

Intervention / Treatment
-----------------
* Drug: 14C-FYU-981


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mass balance