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Completed

NCT Number: NCT02440633

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

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

Completed

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Key information

Conditions

Bacterial Enteritis

Age range

35 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Leeds, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

14C-OPS-2071

Drug

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 12, 2015
Registry last updated
Oct 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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