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

Phase 1

Completed

• Conditions: Healthy Adult Male
• Interventions: Drug: (14C)-OPC-61815

• Registration Number: NCT04182958
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-25
• Study First Submitted: 2019-11-27
• Study First Submitted QC: 2019-11-27
• Study First Posted: 2019-12-02
• Primary Completion: 2019-12-19
• Study Completion: 2019-12-19
• Status Verified: 2021-09
• Results First Submitted: 2021-09-08
• Results First Submitted QC: 2021-09-08
• Last Update Submitted: 2021-09-08
• Results First Posted: 2021-10-06
• Last Update Posted: 2021-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
(14C)-OPC-61815	(14C)-OPC-61815	-

Primary Outcome Measures

Name	Time	Method
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
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
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
t1/2,z - Plasma Total Radioactivity	168 hours after dose
Cmax - Plasma Total Radioactivity	168 hours after dose

Trial Locations

Locations (1)

Covance Clinical Research Unit Ltd; 🇬🇧 Leeds, United Kingdom