Clinical trial NCT02900235: Mass Balance Study of MT-3995
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2016-09-14
Enrollment: 9
Sex: MALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility criteria: 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

Primary outcomes:
measure: Total radioactivity in urine and faeces
timeFrame: up to 99 days
measure: Maximum observed plasma concentration [Cmax]
timeFrame: up to 99 days
measure: Time at which Cmax occurs [tmax]
timeFrame: up to 99 days
measure: Area under the plasma concentration-time curve from time zero to the last measurable concentration [AUC0-t]
timeFrame: up to 99 days
measure: Area under the plasma concentration-time curve from time zero to infinity [AUC0-∞]
timeFrame: up to 99 days
measure: Apparent terminal elimination half-life [t1/2]
timeFrame: up to 99 days
measure: Terminal elimination rate constant [Kel]
timeFrame: up to 99 days
Secondary outcomes:
measure: Safety and tolerability as measured by adverse events (AEs)
timeFrame: up to 99 days
measure: Safety and tolerability as measured by vital signs
timeFrame: up to 99 days
Other outcomes:
Locations:
city: City name
country: United Kingdom
facility: Investigational center
Study officials:
affiliation: Mitsubishi Tanabe Pharma Corporation
name: General Manager
role: STUDY_DIRECTOR
References: