Mass Balance Study of MT-3995

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: MT-3995

• Registration Number: NCT02900235
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-17
• Study First Submitted QC: 2016-09-08
• Study First Posted: 2016-09-14
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-29
• Last Update Posted: 2017-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 9

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MT-3995	MT-3995	\[14C\]-MT-3995 after a single oral dose

Primary Outcome Measures

Name	Time	Method
Terminal elimination rate constant [Kel]	up to 99 days
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Investigational center; 🇬🇧 City name, United Kingdom