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

Phase 1

Completed

• Conditions: Vasomotor Symptoms
• Interventions: Drug: MT-8554 low dose; Drug: MT-8554 middle dose; Drug: MT-8554 high dose; Drug: Placebo

• Registration Number: NCT02803268
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-16
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MT-8554 low dose	Placebo	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.
MT-8554 low dose	MT-8554 low dose	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.
MT-8554 middle dose	MT-8554 middle dose	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.
MT-8554 high dose	MT-8554 high dose	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.
MT-8554 high dose	Placebo	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.
MT-8554 middle dose	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability as measured by number of participants with adverse events	Up to Day 21
Safety and Tolerability as measured by vital signs	Up to Day 21

Secondary Outcome Measures

Name	Time	Method
Plasma concentration of MT-8554 after dosing	Up to Day 15
Frequency of Vasomotor Symptoms	Up to Day 15
Change from baseline in core body temperature	Up to Day 14

Trial Locations

Locations (1)

Investigational center; 🇩🇪 City name, Germany