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Completed

NCT Number: NCT02803268

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

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

Completed

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Key information

Conditions

Vasomotor Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Investigational center

City Name, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MT-8554 Low dose

Drug

MT-8554 middle dose

Drug

MT-8554 High dose

Drug

Placebo

Drug

Primary outcomes

  1. Safety and Tolerability as measured by vital signs

    Time frame: Up to Day 21

  2. Safety and Tolerability as measured by number of participants with adverse events

    Time frame: Up to Day 21

Secondary outcomes

  1. Plasma concentration of MT-8554 after dosing

    Time frame: Up to Day 15

  2. Change from baseline in core body temperature

    Time frame: Up to Day 14

  3. Frequency of Vasomotor Symptoms

    Time frame: Up to Day 15

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 16, 2016
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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