Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
9 participants
INTERVENTIONAL
2016-08-31
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MT-3995
\[14C\]-MT-3995 after a single oral dose
MT-3995
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MT-3995
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
35 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mitsubishi Tanabe Pharma Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
General Manager
Role: STUDY_DIRECTOR
Mitsubishi Tanabe Pharma Corporation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Investigational center
City Name, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MT-3995-E11
Identifier Type: -
Identifier Source: org_study_id