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Mass Balance Study of MT-3995

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02900235
Recruitment Status : Completed
First Posted : September 14, 2016
Last Update Posted : January 31, 2017
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

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

Condition or disease Intervention/treatment Phase
Healthy Drug: MT-3995 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official 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
Study Start Date : August 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: MT-3995
[14C]-MT-3995 after a single oral dose
Drug: MT-3995

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02900235

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United Kingdom
Investigational center
City name, United Kingdom
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
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Study Director: General Manager Mitsubishi Tanabe Pharma Corporation

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Responsible Party: Mitsubishi Tanabe Pharma Corporation Identifier: NCT02900235     History of Changes
Other Study ID Numbers: MT-3995-E11
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Keywords provided by Mitsubishi Tanabe Pharma Corporation: