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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-08-31

Brief Summary

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

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Detailed Description

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Conditions

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Bacterial Enteritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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14C-OPS-2071

Suspension containing 50 mg of 14C-OPS-2071

Group Type EXPERIMENTAL

14C-OPS-2071

Intervention Type DRUG

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

Interventions

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14C-OPS-2071

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes