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

Healthy Adult Male Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04182958
• Other study ID #: 263-102-00006
• Secondary ID: 2019-001968-29
• Status: Completed
• Phase: Phase 1
• Start date: November 25, 2019
• Est. completion date: December 19, 2019

Study information

• Verified date: September 2021
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 19, 2019
• Est. primary completion date: December 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Adult Male

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Unit Ltd	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Concentration-time Curve From Time Zero to Infinity (AUC8) - Plasma OPC-61815 Free Form		48 hours after dose
Primary	Maximum Peak Concentration (Cmax) - Plasma OPC-61815 Free Form		48 hours after dose
Primary	Terminal-phase Elimination Half-life (t1/2,z) - Plasma OPC-61815 Free Form		48 hours after dose
Primary	AUC8 - Plasma OPC-41061		48 hours after dose
Primary	Cmax - Plasma OPC-41061		48 hours after dose
Primary	t1/2,z - Plasma OPC-41061		48 hours after dose
Primary	AUC8 - Plasma Total Radioactivity		168 hours after dose
Primary	Cmax - Plasma Total Radioactivity		168 hours after dose
Primary	t1/2,z - Plasma Total Radioactivity		168 hours after dose