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OpenTrials
Completed

NCT Number: NCT02434835

Study of Absorption, Metabolism and Excretion Following a Single Oral Dose of [14C]KWA-0711 to Healthy Male Subjects

The purpose of this study is to evaluate the absorption, metabolism and excretion following a single oral dose of [14C]KWA-0711 to healthy male subjects.

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Key information

Age range

35 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Leeds, United Kingdom

Who can participate

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

Inclusion criteria

  • Subjects who are male, caucasian, and between 35 and 55 years of age, inclusive.
  • Subjects who have a body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive.
  • Subjects who have a body weight between 50 and 100 kg, inclusive.
  • Subjects must have regular bowel movements.

Exclusion criteria

  • Subjects who have an abnormality in heart rate, blood pressure , temperature or 12-lead ECG.
  • Subjects who are still participating in a clinical study or who have participated in a clinical study involving administration of an investigational drug in the 3 months prior to dose administration.
  • Subjects who have had a clinically significant illness within 4 weeks of dose administration as determined by the Investigator.
  • Subjects who have any clinically significant abnormal laboratory safety findings.
  • Subjects who have had an X ray or who have participated in any clinical 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]KWA-0711

Drug

Primary outcomes

  1. Area under the plasma concentration-time curve (AUC) of total radioactivity, unchanged drug substance and its major metabolites

    Time frame: 240 hours

  2. Maximum observed plasma concentration (Cmax) of total radioactivity, unchanged drug substance and its major metabolites

    Time frame: 240 hours

  3. Cumulative radioactivity recovery in urine and feces

    Time frame: 240 hours

  4. Profiles of metabolites in plasma, urine and faeces

    Time frame: 240 hours

Secondary outcomes

  1. Number of adverse events

    Time frame: 240 hours

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Primary completion
2015
First posted
May 5, 2015
Registry last updated
Apr 18, 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.