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

Overview

- 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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2020

Interventions

  • Drug: (14C)-OPC-61815
    • On the morning of Day 1, all subjects will receive a single IV infusion of (14C) OPC-61815

Arms, Groups and Cohorts

  • Experimental: (14C)-OPC-61815

Clinical Trial Outcome Measures

Primary Measures

  • PK parameter(AUC) for OPC 61815 free form in plasma
    • Time Frame: Predose and 1 hour (end of infusion), and 1.5, 2, 3, 4, 6, 12, 24, and 48 hours after the start of infusion
  • PK parameter(AUC) for OPC-41061 in plasma
    • Time Frame: Predose and 1 hour (end of infusion), and 1.5, 2, 3, 4, 6, 12, 24, and 48 hours after the start of infusion
  • Total radioactivity in Urine and Feces
    • Time Frame: Predose (from Check-in to 0 hours) and 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours after the start of infusion

Participating in This Clinical Trial

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.

Gender Eligibility: Male

Minimum Age: 35 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Otsuka Pharmaceutical Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Osamu Sato, Mr, Study Director, Otsuka Pharmaceutical Co., Ltd.
  • Overall Contact(s)
    • Drug Information Center, +81-3-6361-7314

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