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

NCT04182958 | Completed Phase 1 Results

• 2 other identifiers: 263-102-000062019-001968-29
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Adult Male

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• Cmax - Plasma Total Radioactivity

  168 hours after dose

• t1/2,z - Plasma Total Radioactivity

  168 hours after dose

Study Arms (1)

(14C)-OPC-61815

EXPERIMENTAL

Drug: (14C)-OPC-61815

Interventions

(14C)-OPC-61815 DRUG

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

(14C)-OPC-61815

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Covance Clinical Research Unit Ltd

Leeds, LS2 9LH, United Kingdom

Location

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co., LTD.

CL_OPCJ_RDA_Team@otsuka.jp

+81-3-6361-7366

Study Officials

• Takehisa Matsumaru, Mr

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 2, 2019
• Study Start: November 25, 2019
• Primary Completion: December 19, 2019
• Study Completion: December 19, 2019
• Last Updated: October 6, 2021
• Results First Posted: October 6, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)