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

Otsuka

Status and phase

Completed

Phase 1

Conditions

Bacterial Enteritis

Treatments

Drug: 14C-OPS-2071

Study type

Interventional

Funder types

Industry

Identifiers

341-14-001

Details and patient eligibility

About

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

Enrollment

8 patients

Sex

Male

Ages

35 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.