Back to resultsA 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
Primary Purpose
Bacterial Enteritis
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
14C-OPS-2071
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Enteritis
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
14C-OPS-2071
Arm Description
Suspension containing 50 mg of 14C-OPS-2071
Outcomes
Primary Outcome Measures
The Amounts of Radioactivity Excreted in Urine and Faeces
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
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02440633
First Posted
May 1, 2015
Last Updated
August 30, 2016
Sponsor
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02440633
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To obtain absorption, metabolism and excretion data for parent drug and any metabolites.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Enteritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
14C-OPS-2071
Arm Type
Experimental
Arm Description
Suspension containing 50 mg of 14C-OPS-2071
Intervention Type
Drug
Intervention Name(s)
14C-OPS-2071
Intervention Description
Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly.
Primary Outcome Measure Information:
Title
The Amounts of Radioactivity Excreted in Urine and Faeces
Description
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.
Time Frame
up to144-168h postdose.
Title
Area Under Curve (AUC) of Total Radioactivity in Plasma and Whole Blood
Description
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.
Time Frame
predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.
Title
AUC of OPS-2071 in Plasma
Description
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.
Time Frame
predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshitaka Kotobuki
Organizational Affiliation
Small Global, Division of New Product Evaluation and Development
Official's Role
Study Director
Facility Information:
City
Leeds
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
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
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