Mass Balance Study of MT-3995

NCT02900235 | Completed Phase 1

• 1 other identifier: MT-3995-E11
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Healthy

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• 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

Study Arms (1)

MT-3995

EXPERIMENTAL

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

Drug: MT-3995

Interventions

MT-3995 DRUG

MT-3995

Eligibility Criteria

• Age: 35 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

Investigational center

City Name, United Kingdom

Location

MeSH Terms

Interventions

apararenone

Study Officials

• General Manager

  Tanabe Pharma Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: September 14, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 31, 2017

Record last verified: 2017-01

Locations

GB (1)