A Phase 1,Open -Label Study to Assess the Absorption, Metabolism and Excretion of 14C-OPS-2071 Following a Single Oral Dose to Healthy Male Japanese Subjects

Phase 1CompletedNCT02440633

Otsuka Pharmaceutical Co., Ltd.8 enrolled

Overview

To obtain absorption, metabolism and excretion data for parent drug and any metabolites.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bacterial Enteritis

Interventions

14C-OPS-2071DRUG

Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly.

Eligibility

Sex: MALEMin age: 35 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy males * Body mass index (BMI) between 18.5 and 25.0 kg/m2, inclusive * Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions Exclusion Criteria: * Subjects who have a significant history of alcoholism or drug/chemical abuse, as determined by the Investigator. * Subjects who smoke, or who have used nicotine within 3 months prior to screening.. * Subjects who have a significant history of drug allergy, as determined by the Investigator. * Subjects who have any clinically significant abnormal physical examination finding. * Subjects who have any clinically significant medical history, as determined by the Investigator. * Subjects who are exposed to radiation as a result of their occupation. * Subjects who have had an X ray or CT scan, or who have participated in any trial involving a radiolabelled investigational product or have been exposed to radiolabelled substances within 12 months prior to dose administration.

Locations (1)

Unnamed facility

Leeds, United Kingdom

Outcomes

Primary Outcomes

The Amounts of Radioactivity Excreted in Urine and Faeces

A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We evaluated the cumulative excretion of total radioactivity (%) in feces and urine, up to 168 hours postdose.

Time frame: up to144-168h postdose.

Area Under Curve (AUC) of Total Radioactivity in Plasma and Whole Blood

A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We measured total radioactivity in plasma and whole blood each. We evaluated AUC 0-168h of total radioactivity in plasma and whole blood each. The AUCs in plasma and whole blood are of total radioactivity including the parent and metabolites.

Time frame: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.

AUC of OPS-2071 in Plasma

A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We measured OPS-2071 concentration in plasma and evaluated AUC 0-168h of OPS-2071 in plasma.

Time frame: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.

Data from ClinicalTrials.gov

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