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

Vasomotor Symptoms Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02803268
• Other study ID #: MT-8554-E04
• 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
• 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

Related Conditions & MeSH terms

• Vasomotor Symptoms

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