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

Otsuka

Status and phase

Completed

Phase 1

Conditions

Healthy Adult Male

Treatments

Drug: (14C)-OPC-61815

Study type

Interventional

Funder types

Industry

Identifiers

263-102-00006

2019-001968-29 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

8 patients

Sex

Male

Ages

35 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.