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

August 30, 2016 updated by: Otsuka Pharmaceutical Co., Ltd.
To obtain absorption, metabolism and excretion data for parent drug and any metabolites.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 14C-OPS-2071
Suspension containing 50 mg of 14C-OPS-2071
Drug: 14C-OPS-2071
Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Co., Ltd.

Investigators

  • Study Director: Yoshitaka Kotobuki, Small Global, Division of New Product Evaluation and Development

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

May 1, 2015

First Submitted That Met QC Criteria

May 7, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Estimate)

October 21, 2016

Last Update Submitted That Met QC Criteria

August 30, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 341-14-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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