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

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ClinicalTrials.gov Identifier: NCT02803268
Recruitment Status : Completed
First Posted : June 16, 2016
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Vasomotor Symptoms Drug: MT-8554 low dose Drug: MT-8554 middle dose Drug: MT-8554 high dose Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Study Start Date : June 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Arm Intervention/treatment
Experimental: 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.
Drug: MT-8554 low dose
Drug: Placebo
Experimental: 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.
Drug: MT-8554 middle dose
Drug: Placebo
Experimental: 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.
Drug: MT-8554 high dose
Drug: Placebo



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02803268


Locations
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Germany
Investigational center
City name, Germany
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
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Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT02803268    
Other Study ID Numbers: MT-8554-E04
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017