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

Tanabe Pharma Corporation

Status and phase: Completed; Phase 1

Conditions: Vasomotor Symptoms

Treatments: Drug: MT-8554 high dose; Drug: MT-8554 middle dose; Drug: Placebo; Drug: MT-8554 low dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02803268

MT-8554-E04

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 3 patient groups

MT-8554 low dose

Experimental group

Description:

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.

Treatment:

Drug: MT-8554 low dose

Drug: Placebo

MT-8554 middle dose

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: MT-8554 middle dose

MT-8554 high dose

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: MT-8554 high dose