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

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

Sponsors

Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Source Otsuka Pharmaceutical Co., Ltd.
Brief Summary

- 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

Overall Status Recruiting
Start Date December 2019
Completion Date February 2020
Primary Completion Date February 2020
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
PK parameter(AUC) for OPC 61815 free form in plasma 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 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 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
Enrollment 6
Condition
Intervention

Intervention Type: Drug

Intervention Name: (14C)-OPC-61815

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

Arm Group Label: (14C)-OPC-61815

Eligibility

Criteria:

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: Male

Minimum Age: 35 Years

Maximum Age: 55 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Osamu Sato, Mr Study Director Otsuka Pharmaceutical Co., Ltd.
Overall Contact

Last Name: Drug Information Center

Phone: +81-3-6361-7314

Location
Facility: Status: Covance Clinical Research Unit Ltd
Location Countries

United Kingdom

Verification Date

November 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 1
Arm Group

Label: (14C)-OPC-61815

Type: Experimental

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov