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... | NCT02440633 | Trialant
CompletedInterventionalPhase 1Updated Oct 21, 2016
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
ClinicalTrials.gov ID
NCT02440633
Lead Sponsor
Otsuka Pharmaceutical Co., Ltd.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1
Enrollment
8Actual
Last Update Posted
Oct 21, 2016Estimated
Start Date
May 2015
Primary Completion Date
Aug 2015Actual
Completion Date
Aug 2015Actual
Brief Summary
To obtain absorption, metabolism and excretion data for parent drug and any metabolites.
Bacterial Enteritis
14C-OPS-2071
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
Male
Accepts Healthy Volunteers
Yes
Eligibility 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.