Mass Balance Study of MT-3995

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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: MT-3995


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MT-3995<br>[14C]-MT-3995 after a single oral dose | Drug: MT-3995<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total radioactivity in urine and faeces |  | up to 99 days | 
| Maximum observed plasma concentration [Cmax] |  | up to 99 days | 
| Time at which Cmax occurs [tmax] |  | up to 99 days | 
| Area under the plasma concentration-time curve from time zero to the last measurable concentration [AUC0-t] |  | up to 99 days | 
| Area under the plasma concentration-time curve from time zero to infinity [AUC0-∞] |  | up to 99 days | 
| Apparent terminal elimination half-life [t1/2] |  | up to 99 days | 
| Terminal elimination rate constant [Kel] |  | up to 99 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability as measured by adverse events (AEs) |  | up to 99 days | 
| Safety and tolerability as measured by vital signs |  | up to 99 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy