The purpose of this study is to investigate the absorption, metabolism and excretion of
MT-3995 in healthy subjects.
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Locations near you
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Full eligibility criteria for NCT02900235
Ages eligible for Study
35 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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
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
All locations for NCT02900235
United Kingdom (1)
City name, United Kingdom
View full eligibility
Tris trial is registered with FDA with number: NCT02900235. The sponsor of the trial is Mitsubishi Tanabe Pharma Corporation and it is looking for 9 volunteers for the current phase.
Official trial 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
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