A Phase 1,Open -Label Study to Assess the Absorption, Metabolism and Excretion of 14C-OPS-2071 Following a Single Oral Dose to Healthy Male Japanese Subjects

Study Overview
=================
Brief Summary
-----------------
To obtain absorption, metabolism and excretion data for parent drug and any metabolites.

Conditions
-----------------
Bacterial Enteritis

Intervention / Treatment
-----------------
* Drug: 14C-OPS-2071


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males Body mass index (BMI) between 18.5 and 25.0 kg/m2, inclusive Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions Exclusion Criteria: Subjects who have a significant history of alcoholism or drug/chemical abuse, as determined by the Investigator. Subjects who smoke, or who have used nicotine within 3 months prior to screening.. Subjects who have a significant history of drug allergy, as determined by the Investigator. Subjects who have any clinically significant abnormal physical examination finding. Subjects who have any clinically significant medical history, as determined by the Investigator. Subjects who are exposed to radiation as a result of their occupation. Subjects who have had an X ray or CT scan, or who have participated in any trial involving a radiolabelled investigational product or have been exposed to radiolabelled substances within 12 months prior to dose administration.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 14C-OPS-2071<br>Suspension containing 50 mg of 14C-OPS-2071 | Drug: 14C-OPS-2071<br>* Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Amounts of Radioactivity Excreted in Urine and Faeces | A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We evaluated the cumulative excretion of total radioactivity (%) in feces and urine, up to 168 hours postdose. | up to144-168h postdose. | 
| Area Under Curve (AUC) of Total Radioactivity in Plasma and Whole Blood | A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We measured total radioactivity in plasma and whole blood each. We evaluated AUC 0-168h of total radioactivity in plasma and whole blood each. The AUCs in plasma and whole blood are of total radioactivity including the parent and metabolites. | predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose. | 
| AUC of OPS-2071 in Plasma | A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We measured OPS-2071 concentration in plasma and evaluated AUC 0-168h of OPS-2071 in plasma. | predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose. |