Clinical 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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

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

Detailed Summary:
Sponsor: Otsuka Pharmaceutical Co., Ltd.

Current Primary Outcome:

  • 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.


Original Primary Outcome:

  • The Amounts of Radioactivity Excreted in Urine and Faeces [ Time Frame: up to144-168h 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. ]
  • 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. ]


Current Secondary Outcome:

Original Secondary Outcome: Number of Adverse Events [ Time Frame: Screening, Day-1，0-168h postdose ]

Information By: Otsuka Pharmaceutical Co., Ltd.

Dates:
Date Received: May 1, 2015
Date Started: May 2015
Date Completion:
Last Updated: August 30, 2016
Last Verified: August 2016