A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of MT-8554 in Female Subjects Experiencing Vasomotor Symptoms | NCT02803268 | Trialant
CompletedInterventionalPhase 1Updated Dec 22, 2025
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of MT-8554 in Female Subjects Experiencing Vasomotor Symptoms
ClinicalTrials.gov ID
NCT02803268
Lead Sponsor
Tanabe Pharma CorporationINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1
Enrollment
24Actual
Last Update Posted
Dec 22, 2025Actual
Start Date
Jun 2016
Primary Completion Date
Jan 2017Actual
Completion Date
Jan 2017Actual
Brief Summary
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of MT-8554 in Female Subjects Experiencing Vasomotor Symptoms
Vasomotor Symptoms
MT-8554 low dose
MT-8554 middle dose
MT-8554 high dose
Placebo
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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