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The purpose of this study is to investigate the absorption, metabolism and excretion of MT-3995 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT-3995 | Experimental | [14C]-MT-3995 after a single oral dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-3995 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| General Manager | Tanabe Pharma Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational center | City Name | United Kingdom |
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| ID | Term |
|---|---|
| C000719999 | apararenone |
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