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Completed

NCT Number: NCT04182958

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

* 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

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Key information

Conditions

Healthy Adult Male

Age range

35 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit Ltd

Leeds, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

(14C)-OPC-61815

Drug

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

Primary outcomes

  1. Area Under the Concentration-time Curve From Time Zero to Infinity (AUC∞) - Plasma OPC-61815 Free Form

    Time frame: 48 hours after dose

  2. Maximum Peak Concentration (Cmax) - Plasma OPC-61815 Free Form

    Time frame: 48 hours after dose

  3. Terminal-phase Elimination Half-life (t1/2,z) - Plasma OPC-61815 Free Form

    Time frame: 48 hours after dose

  4. AUC∞ - Plasma OPC-41061

    Time frame: 48 hours after dose

  5. Cmax - Plasma OPC-41061

    Time frame: 48 hours after dose

  6. t1/2,z - Plasma OPC-41061

    Time frame: 48 hours after dose

  7. AUC∞ - Plasma Total Radioactivity

    Time frame: 168 hours after dose

  8. Cmax - Plasma Total Radioactivity

    Time frame: 168 hours after dose

  9. t1/2,z - Plasma Total Radioactivity

    Time frame: 168 hours after dose

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 2, 2019
Registry last updated
Oct 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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