Mass Balance Study of MT-3995

Mitsubishi Tanabe Pharma

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: MT-3995

Study type

Interventional

Funder types

Industry

Identifiers

MT-3995-E11

Details and patient eligibility

About

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

Enrollment

9 patients

Sex

Male

Ages

35+ years old

Volunteers

Accepts Healthy Volunteers

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