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The purpose of this study is to investigate the safety and tolerability of ascending single and multiple oral doses of MT-4129 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single ascending dose, MT-4129 or Placebo | Experimental |
| |
| Multiple ascending dose, MT-4129 or Placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-4129 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability as measured by incidence and severity of adverse events | Up to Day 14 | |
| Safety and Tolerability as measured by vital signs | Up to Day 14 | |
| Safety and Tolerability as measured by ECG | Up to Day 14 | |
| Safety and Tolerability as measured by clinical laboratory assessments | Up to Day 14 | |
| Safety and Tolerability as measured by Hormone assessments | Up to Day 10 | |
| Safety and Tolerability as measured by physical examination | Up to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of MT-4129 | Up to Day 10 | |
| Measured time of maximum observed plasma concentration (tmax) of MT-4129 | Up to Day 10 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| General Manager | Tanabe Pharma Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaceutical Research Associates (PRA) Health Sciences | City Name | Netherlands |
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| Drug |
|
| Apparent terminal elimination half-life (t1/2) of MT-4129 |
| Up to Day 10 |
| AUC from time zero to 24 hours post-dose (AUC0-24) of MT-4129 | Up to Day 8 |
| AUC from time zero to 48 hours post-dose (AUC0-48) of MT-4129 | Up to Day 9 |
| AUC from time zero to 72 hours post-dose (AUC0-72) of MT-4129 | Up to Day 10 |
| AUC from time zero to infinity (AUC0-∞) of MT-4129 | Up to Day 10 |
| AUC from time zero to the last measurable concentration (AUC0-last) of MT-4129 | Up to Day 10 |
| AUC over the dosing interval (AUC0-t) of MT-4129 | Up to Day 10 |
| Terminal elimination rate constant (Kel) of MT-4129 | Up to Day 10 |
| Mean residence time (MRT) of MT-4129 | Up to Day 10 |
| Apparent volume of distribution during terminal phase after oral administration (Vz/F) of MT-4129 | Up to Day 10 |
| Apparent volume of distribution at steady state (Vss/F) of MT-4129 | Up to Day 10 |
| Apparent oral clearance (CL/F) of MT-4129 | Up to Day 10 |
| Urinary excreted amount of test compound (Ae) of MT-4129 | Up to Day 10 |
| Urinary excreted amount of test compound expressed as a percentage of the dose administered (Ae%) of MT-4129 | Up to Day 10 |
| Renal clearance (CLR) of MT-4129 | Up to Day 10 |
| Plasma aldosterone | Up to Day 10 |
| Serum cortisol | Up to Day 10 |
| Plasma steroid hormones | Up to Day 10 |
| Urinary aldosterone | Up to Day 10 |
| Urinary cortisol | Up to Day 10 |
| Urinary sodium | Up to Day 10 |
| Urine potassium | Up to Day 10 |