Overview

This trial is active, not recruiting.

Condition healthy
Treatment mt-3995
Phase phase 1
Sponsor Mitsubishi Tanabe Pharma Corporation
Start date August 2016
End date December 2016
Trial size 9 participants
Trial identifier NCT02900235, MT-3995-E11

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacokinetics study
Intervention model single group assignment
Masking open label
Arm
(Experimental)
[14C]-MT-3995 after a single oral dose
mt-3995

Primary Outcomes

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

Secondary Outcomes

Measure
Safety and tolerability as measured by adverse events (AEs)
time frame: up to 99 days
Safety and tolerability as measured by vital signs
time frame: up to 99 days

Eligibility Criteria

Male participants at least 35 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Mitsubishi Tanabe Pharma Corporation.