Mass Balance Study of MT-3995

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: MT-3995

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • City name, United Kingdom
    • Investigational center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Mitsubishi Tanabe Pharma Corporation

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: August 17, 2016
• First Submitted That Met QC Criteria: September 8, 2016
• First Posted (Estimate): September 14, 2016

Study Record Updates

• Last Update Posted (Estimate): January 31, 2017
• Last Update Submitted That Met QC Criteria: January 29, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Healthy
• Other Study ID Numbers: MT-3995-E11