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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04182958

Enrollment

Registered

2019-12-02

Start date

2019-11-25

Completion date

2019-12-19

Last updated

2021-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adult Male

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

Interventions

DRUG(14C)-OPC-61815

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

35 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

United Kingdom

Participant flow

Participants by arm

Arm	Count
Overall: (14C)-OPC-61815 Subjects were to receive a single IV infusion of 16 mg (14C)-OPC-61815, containing approximately 75.1 μCi (2.78 MBq), over a period of 60 minutes (55 to 65 minutes, inclusive) on Day 1 of the trial.	8
Total	8

Baseline characteristics

Characteristic	Overall: (14C)-OPC-61815
Age, Continuous	43 years STANDARD_DEVIATION 5.8
Race/Ethnicity, Customized Japanese	8 Participants
Region of Enrollment United Kingdom	8 Participants
Sex: Female, Male Female	0 Participants
Sex: Female, Male Male	8 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 8
other Total, other adverse events	1 / 8
serious Total, serious adverse events	0 / 8