check_circleStudy Completed

Vasomotor Symptoms as a sex hormone-dependent disorder in women and men

A study to learn how safe elinzanetant is, how it affects the body, and how it moves into, through and out of the body after single and multiple doses in Japanese healthy female adults

Trial purpose

Researchers are looking for a new way to treat women who have symptoms that are caused by the sex hormonal changes that happen when a woman’s body is going through the menopause. These symptoms include Vasomotor Symptoms (VMS) (hot flashes), and changes in blood pressure. Menopause is when women stop having a menstrual cycle, also called a period. During the period, the ovaries increasingly produce less sex hormones as a result of the natural ageing process and related hormonal adjustments. The decline in hormone production can lead to various symptoms which, in some cases, can have a very adverse effect on a menopausal woman's quality of life.

In this study, researchers want to learn more about a new substance called elinzanetant. Elinzanetant was developed to treat symptoms caused by sex hormonal changes. It works by blocking a group of proteins called neurokinins from sending signals to other parts of the body, which play a role in starting the symptoms.

In this study, the researchers will learn how safe elinzanetant is and how it affects the body of healthy Japanese women compared to a placebo. A placebo is a treatment that looks like a medicine but does not have any medicine in it. Before a new treatment can be given to patients, researchers do studies in healthy participants to learn more about its safety and how it acts in the body.

There will be 2 parts to this study. In Part A, the participants will take a single dose of either elinzanetant or the placebo. In Part B, the participants will take multiple doses of elinzanetant or the placebo. The participants will take each study treatment as capsules by mouth.

The main purpose of this study is to learn how safe elinzanetant is and how it affects the body. To answer this question, the researchers will collect the medical problems the participants have after receiving the treatment and that may or may not be related to the study treatment. These medical problems are also known as “adverse events”.

During Part A, the participants will stay at their study site for a total of 9 days. They will take either elinzanetant or the placebo only on Day 1 of their stay. During Part B, the participants will stay at their study site for a total of 15 days. They will take either elinzanetant or the placebo once a day for 7 days of their stay. Each participant will be in the study for a total of approximately 5 weeks for Part A and approximately 6 weeks for Part B.

During the study, the doctors will:
•   take blood and urine samples;
•   check the participants’ health;
•   ask the participants questions about what medicines they are taking and if they are having adverse events.

Key Participants Requirements

Sex

Female

Age

40 - 65 Years

Trial summary

Enrollment Goal
62
Trial Dates
August 2021 - March 2022
Phase
Phase 1
Could I Receive a placebo
Yes
Products
Lynkuet (Elinzanetant, BAY3427080)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
SOUSEIKAI Fukuoka Mirai HospitalFukuoka, 813-0017, Japan

Primary Outcome

  • Number of participants with and severity of treatment-emergent adverse events (TEAEs)
    date_rangeTime Frame:
    Up to 2 weeks after start of dosing

Secondary Outcome

  • Cmax (maximum observed drug concentration after single dose administration) of elinzanetant
    Only for single dose steps 1 to 4 and 6
    date_rangeTime Frame:
    Day 1 pre-dose until 144 hours post-dose
  • Cmax/D (Cmax divided by dose) of elinzanetant
    Only for single dose steps 1 to 4 and 6
    date_rangeTime Frame:
    Day 1 pre-dose until 144 hours post-dose
  • AUC (area under the concentration vs. time curve from zero to infinity after single dose) of elinzanetant
    Only for single dose steps 1 to 4 and 6
    date_rangeTime Frame:
    Day 1 pre-dose until 144 hours post-dose
  • AUC/D (AUC divided by dose) of elinzanetant
    Only for single dose steps 1 to 4 and 6
    date_rangeTime Frame:
    Day 1 pre-dose until 144 hours post-dose
  • Cmax,md (maximum observed drug concentration after multiple dose administration) of elinzanetant
    Only for multiple dose step 5
    date_rangeTime Frame:
    Day 7 (pre-dose until 144 hours post-dose)
  • Cmax,md/D (Cmax,md divided by dose) of elinzanetant
    Only for multiple dose step 5
    date_rangeTime Frame:
    Day 7 (pre-dose until 144 hours post-dose)
  • AUC(0-24)md (AUC from time 0 to 24 h after multiple dose) of elinzanetant
    Only for multiple dose step 5
    date_rangeTime Frame:
    Day 7 (pre-dose until 24 hours post-dose)
  • AUC(0-24)md/D (AUC(0-24)md divided by dose) of elinzanetant
    Only for multiple dose step 5
    date_rangeTime Frame:
    Day 7 (pre-dose until 24 hours post-dose)

Trial design

A randomized, placebo-controlled, single-blind, dose escalation study to investigate the safety, tolerability and pharmacokinetics after single and multiple dose of elinzanetant in Japanese healthy female adult participants
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
N/A
Assignment
Sequential Assignment
Trial Arms
6

Additional Information