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
Overview
- Phase
- Phase 1
- Intervention
- 14C-OPS-2071
- Conditions
- Bacterial Enteritis
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Enrollment
- 8
- Primary Endpoint
- The Amounts of Radioactivity Excreted in Urine and Faeces
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
To obtain absorption, metabolism and excretion data for parent drug and any metabolites.
Investigators
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.
Arms & Interventions
14C-OPS-2071
Suspension containing 50 mg of 14C-OPS-2071
Intervention: 14C-OPS-2071
Outcomes
Primary Outcomes
The Amounts of Radioactivity Excreted in Urine and Faeces
Time Frame: up to144-168h postdose.
A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We evaluated the cumulative excretion of total radioactivity (%) in feces and urine, up to 168 hours postdose.
Area Under Curve (AUC) of Total Radioactivity in Plasma and Whole Blood
Time Frame: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.
A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We measured total radioactivity in plasma and whole blood each. We evaluated AUC 0-168h of total radioactivity in plasma and whole blood each. The AUCs in plasma and whole blood are of total radioactivity including the parent and metabolites.
AUC of OPS-2071 in Plasma
Time Frame: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.
A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We measured OPS-2071 concentration in plasma and evaluated AUC 0-168h of OPS-2071 in plasma.