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Completed

NCT Number: NCT02900235

Mass Balance Study of MT-3995

The purpose of this study is to investigate the absorption, metabolism and excretion of MT-3995 in healthy subjects.

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Key information

Conditions

Age range

35 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Investigational center

City Name, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Able to provide written informed consent to participate in the study
  • Caucasian male aged at least 35 years at Screening
  • Healthy and free from clinically significant illness or disease at Screening and Day-1
  • A body weight of 60 to 110 kg at Screening and Day-1
  • Vital signs within the following ranges at Screening, Day-1 and Pre-dose:
  • Body temperature : 35.0°C to 37.5°C
  • Systolic blood pressure: 90 to 140 mmHg
  • Diastolic blood pressure: 50 to 90 mmHg
  • Regular daily bowel movements

Exclusion criteria

  • Presence or history of severe adverse reaction or allergy to any medicinal product
  • Participation in more than three clinical studies of an Investigational Medicinal Product (IMP) in the previous year or participated in a clinical study of any IMP within 12 weeks or five half-lives
  • Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardise the subject in case of participation in the study. The Investigator should be guided by evidence of any of the following:
  • History of inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or rectal bleeding considered clinically significant by the Investigator
  • History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bowel resection
  • History or clinical evidence of pancreatic injury or pancreatitis

Treatment and study plan

MT-3995

Drug

Primary outcomes

  1. Total radioactivity in urine and faeces

    Time frame: up to 99 days

  2. Maximum observed plasma concentration [Cmax]

    Time frame: up to 99 days

  3. Time at which Cmax occurs [tmax]

    Time frame: up to 99 days

  4. Area under the plasma concentration-time curve from time zero to the last measurable concentration [AUC0-t]

    Time frame: up to 99 days

  5. Area under the plasma concentration-time curve from time zero to infinity [AUC0-∞]

    Time frame: up to 99 days

  6. Apparent terminal elimination half-life [t1/2]

    Time frame: up to 99 days

  7. Terminal elimination rate constant [Kel]

    Time frame: up to 99 days

Secondary outcomes

  1. Safety and tolerability as measured by adverse events (AEs)

    Time frame: up to 99 days

  2. Safety and tolerability as measured by vital signs

    Time frame: up to 99 days

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

An Open-label, Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C]-MT-3995 After a Single Oral Dose to Healthy Male Subjects

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 14, 2016
Registry last updated
Jan 31, 2017

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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