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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02803268
Other study ID # MT-8554-E04
Secondary ID
Status Completed
Phase Phase 1
First received June 14, 2016
Last updated February 9, 2017
Start date June 2016
Est. completion date January 2017

Study information

Verified date February 2017
Source Mitsubishi Tanabe Pharma Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
MT-8554 low dose

MT-8554 middle dose

MT-8554 high dose

Placebo


Locations

Country Name City State
Germany Investigational center City name

Sponsors (1)

Lead Sponsor Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and Tolerability as measured by vital signs Up to Day 21
Primary Safety and Tolerability as measured by number of participants with adverse events Up to Day 21
Secondary Plasma concentration of MT-8554 after dosing Up to Day 15
Secondary Change from baseline in core body temperature Up to Day 14
Secondary Frequency of Vasomotor Symptoms Up to Day 15
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