A Phase I, Open-Label Trial to Assess the Absorption, Metabolism, and Excretion of (14C)-OPC-61815 in Healthy Male Japanese Subjects

Study Overview
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Brief Summary
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To determine the mass balance of totalradioactivity following a single IV infusionof (14C)-OPC-61815. To determine routes and rates of elimination of total radioactivity following a single IV infusion of (14C)-OPC-61815 To assess the PK of total radioactivity in plasma and whole blood following a single IV infusion of (14C)-OPC-61815 To assess the PK of OPC-61815 free form and OPC-41061 in plasma following a single IV infusion of (14C)-OPC-61815

Official Title
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A Phase I, Open-Label Trial to Assess the Mass Balance and Pharmacokinetics of a Single Intravenous Administration of (14C)-OPC-61815 to Healthy Male Japanese Subjects

Conditions
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Healthy Adult Male

Intervention / Treatment
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* Drug: (14C)-OPC-61815


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male subjects between 35 and 55 years of age, inclusive; hold a valid Japanese passport and be first generation Japanese, defined as the subject, the subject's biological parent, and all of the subject's biological grandparents being of exclusive Japanese descent, have been born in Japan, and not lived outside of Japan for more than 5 years; with a body mass index between 18.5 and 28.0 kg/m2, inclusive, and a total body weight between 50 and 100 kg, inclusive; in good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, and clinical laboratory evaluations at Screening and Check in as assessed by the investigator (or designee); and have a history of a minimum of 1 bowel movement per day. Exclusion Criteria: History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion; poor peripheral venous access; participation in a clinical trial involving administration of an investigational drug in the past 90 days prior to dosing; subjects with exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in; subjects who have participated in any clinical trial involving a radiolabeled investigational drug within 12 months prior to Check-in.

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

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: (14C)-OPC-61815<br> | Drug: (14C)-OPC-61815<br>* On the morning of Day 1, all subjects will receive a single IV infusion of (14C) OPC-61815<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Concentration-time Curve From Time Zero to Infinity (AUC∞) - Plasma OPC-61815 Free Form |  | 48 hours after dose | 
| Maximum Peak Concentration (Cmax) - Plasma OPC-61815 Free Form |  | 48 hours after dose | 
| Terminal-phase Elimination Half-life (t1/2,z) - Plasma OPC-61815 Free Form |  | 48 hours after dose | 
| AUC∞ - Plasma OPC-41061 |  | 48 hours after dose | 
| Cmax - Plasma OPC-41061 |  | 48 hours after dose | 
| t1/2,z - Plasma OPC-41061 |  | 48 hours after dose | 
| AUC∞ - Plasma Total Radioactivity |  | 168 hours after dose | 
| Cmax - Plasma Total Radioactivity |  | 168 hours after dose | 
| t1/2,z - Plasma Total Radioactivity |  | 168 hours after dose |