Mass Balance Study of MT-3995

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02900235
• Other study ID #: MT-3995-E11
• Status: Completed
• Phase: Phase 1
• First received: August 17, 2016
• Last updated: January 29, 2017
• Start date: August 2016
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• MT-3995

Locations

Country	Name	City	State
United Kingdom	Investigational center	City name

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total radioactivity in urine and faeces		up to 99 days
Primary	Maximum observed plasma concentration [Cmax]		up to 99 days
Primary	Time at which Cmax occurs [tmax]		up to 99 days
Primary	Area under the plasma concentration-time curve from time zero to the last measurable concentration [AUC0-t]		up to 99 days
Primary	Area under the plasma concentration-time curve from time zero to infinity [AUC0-8]		up to 99 days
Primary	Apparent terminal elimination half-life [t1/2]		up to 99 days
Primary	Terminal elimination rate constant [Kel]		up to 99 days
Secondary	Safety and tolerability as measured by adverse events (AEs)		up to 99 days
Secondary	Safety and tolerability as measured by vital signs		up to 99 days