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A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of MT-8554 in Female Subjects Experiencing Vasomotor Symptoms
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT-8554 low dose | Experimental | Patients who meet eligibility criteria will be administered once daily either low dose of MT-8554 or a matching Placebo from Day 1 to 14. |
|
| MT-8554 middle dose | Experimental | Patients who meet eligibility criteria will be administered once daily either middle dose of MT-8554 or a matching Placebo from Day 1 to 14. |
|
| MT-8554 high dose | Experimental | Patients who meet eligibility criteria will be administered once daily either high dose of MT-8554 or a matching Placebo from Day 1 to 14. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-8554 low dose | Drug |
| ||
| MT-8554 middle dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability as measured by vital signs | Up to Day 21 | |
| Safety and Tolerability as measured by number of participants with adverse events | Up to Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of MT-8554 after dosing | Up to Day 15 | |
| Change from baseline in core body temperature | Up to Day 14 | |
| Frequency of Vasomotor Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational center | City Name | Germany |
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| MT-8554 high dose | Drug |
|
| Placebo | Drug |
|
| Up to Day 15 |