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

NCT02803268 | Completed Phase 1

• 1 other identifier: MT-8554-E04
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vasomotor Symptoms

Outcome Measures

Primary Outcomes (2)

• Safety and Tolerability as measured by vital signs

  Up to Day 21

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

  Up to Day 21

Secondary Outcomes (3)

• Plasma concentration of MT-8554 after dosing

  Up to Day 15

• Change from baseline in core body temperature

  Up to Day 14

• Frequency of Vasomotor Symptoms

  Up to Day 15

Study Arms (3)

MT-8554 low dose

EXPERIMENTAL

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

MT-8554 middle dose

EXPERIMENTAL

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

MT-8554 high dose

EXPERIMENTAL

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

Interventions

MT-8554 low dose DRUG

MT-8554 low dose

MT-8554 middle dose DRUG

MT-8554 middle dose

MT-8554 high dose DRUG

MT-8554 high dose

Placebo DRUG

MT-8554 high dose; MT-8554 low dose; MT-8554 middle dose

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

Investigational center

City Name, Germany

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 16, 2016
• Study Start: June 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

DE (1)