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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

NCT02440633 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2016-10-21

Study results available
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Summary

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

Conditions

  • Bacterial Enteritis

Interventions

DRUG

14C-OPS-2071

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

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yoshitaka Kotobuki · Small Global, Division of New Product Evaluation and Development

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02440633 on ClinicalTrials.gov