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 1

Completed

• Conditions: Bacterial Enteritis
• Interventions: Drug: 14C-OPS-2071

• Registration Number: NCT02440633
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-01
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-12
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Results First Submitted: 2016-07-10
• Results First Submitted QC: 2016-07-10
• Status Verified: 2016-08
• Results First Posted: 2016-08-24
• Last Update Submitted: 2016-08-30
• Last Update Posted: 2016-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
14C-OPS-2071	14C-OPS-2071	Suspension containing 50 mg of 14C-OPS-2071

Primary Outcome Measures

Name	Time	Method
The Amounts of Radioactivity Excreted in Urine and Faeces	up to144-168h postdose.	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.
Area Under Curve (AUC) of Total Radioactivity in Plasma and Whole Blood	predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.	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.
AUC of OPS-2071 in Plasma	predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.	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.