Vasomotor Symptoms
Conditions
Brief summary
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of MT-8554 in Female Subjects Experiencing Vasomotor Symptoms
Interventions
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Germany
Outcome results
None listed