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

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Criteria

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.