Healthy
Conditions
Keywords
Healthy
Brief summary
The purpose of this study is to investigate the absorption, metabolism and excretion of MT-3995 in healthy subjects.
Interventions
DRUGMT-3995
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
35 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Terminal elimination rate constant [Kel] | 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 |
| Maximum observed plasma concentration [Cmax] | up to 99 days |
| Time at which Cmax occurs [tmax] | up to 99 days |
| Total radioactivity in urine and faeces | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability as measured by vital signs | up to 99 days |
| Safety and tolerability as measured by adverse events (AEs) | up to 99 days |
Countries
United Kingdom
Outcome results
None listed