A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of MT-8554 in Female Subjects Experiencing Vasomotor Symptoms

Study Overview
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Brief Summary
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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

Conditions
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Vasomotor Symptoms

Intervention / Treatment
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* Drug: MT-8554 low dose
* Drug: MT-8554 middle dose
* Drug: MT-8554 high dose
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must meet one of the following criteria:Woman aged ≥18 years with histologically proven non-metastatic breast cancer (Stages I, II or III) and without evidence of disease / Woman aged ≥40 years who are post-menopausal / Woman aged ≥40 years who are peri-menopausal Subjects who have ≥7 Vasomotor Symptoms per day on average A body weight of ≥45 kg Exclusion Criteria: Participation in more than three clinical studies involving administration of an unlicensed Investigational Medicinal Product in the previous year, or any study within 12 weeks Clinically significant endocrine, thyroid, hepatic, respiratory, gastro-intestinal, renal, cardiovascular disease, or history of any significant psychiatric/psychotic illness disorder Clinically relevant abnormal medical history, physical findings or laboratory values

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MT-8554 low dose<br>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. | Drug: MT-8554 low dose<br> <br> Drug: Placebo<br> <br> |
| Experimental: MT-8554 middle dose<br>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. | Drug: MT-8554 middle dose<br> <br> Drug: Placebo<br> <br> |
| Experimental: MT-8554 high dose<br>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. | Drug: MT-8554 high dose<br> <br> Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | Up to Day 15 |