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

Sponsors

Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Source Otsuka Pharmaceutical Co., Ltd.
Brief Summary

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

Overall Status Completed
Start Date 2015-05-01
Completion Date 2015-08-01
Primary Completion Date 2015-08-01
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
The Amounts of Radioactivity Excreted in Urine and Faeces up to144-168h postdose.
Area Under Curve (AUC) of Total Radioactivity in Plasma and Whole Blood predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.
AUC of OPS-2071 in Plasma predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.
Enrollment 8
Condition
Intervention

Intervention Type: Drug

Intervention Name: 14C-OPS-2071

Description: Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly.

Arm Group Label: 14C-OPS-2071

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.

Gender:

Male

Minimum Age:

35 Years

Maximum Age:

55 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Yoshitaka Kotobuki Study Director Small Global, Division of New Product Evaluation and Development
Location
Facility:
Location Countries

United Kingdom

Verification Date

2016-08-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: 14C-OPS-2071

Type: Experimental

Description: Suspension containing 50 mg of 14C-OPS-2071

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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