check_circleStudy Completed

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

A study to learn how different levels of decreased liver function influence blood levels of elinzanetant compared to normal liver function in male and female participants

Trial purpose

Researchers are looking for a better way to treat people who have symptoms caused by hormonal changes, like those that happen in women during menopause. These symptoms can include vasomotor symptoms. Before a treatment can be approved for patients to take, researchers do clinical studies to better understand its safety and what happens to the treatment in the body.
The study drug, elinzanetant, was designed to treat vasomotor symptoms. The liver plays an important role in removing elinzanetant from the body. Therefore, this study is done to find out how reduced liver function influences the removal of elinzanetant.
The study will include male and female participants who are 18 to 75 years old. One part of the participants will have mildly or moderately impaired hepatic function. For each group with impaired hepatic function, a group with normal hepatic function will be included.
Blood and urine samples will be collected. The physician will also check the participants’ heart health using an electrocardiogram (ECG). The participants will answer questions about their well-being and taken medications.
The researchers will compare the blood levels of elinzanetant in the participants with impaired hepatic function to those of the matched participants with normal hepatic function. This way, they can see how blood levels of elinzanetant are influenced by liver function. This information is important for giving recommendations on dosing in patients with impaired hepatic function.

Key Participants Requirements

Sex

All

Age

18 - N/A

Trial summary

Enrollment Goal
33
Trial Dates
June 2021 - March 2022
Phase
Phase 1
Could I Receive a placebo
No
Products
Lynkuet (Elinzanetant, BAY3427080)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
APEX GmbHMünchen, 81241, Germany
Completed
CRS Clinical-Research-Services Kiel GmbHKiel, 24105, Germany

Primary Outcome

  • Cmax,md,u of elinzanetant
    Cmax,md,u: Maximum observed drug concentration in measured matrix after multiple dose administration during a dosage interval of the unbound analyte.
    date_rangeTime Frame:
    On day 8
  • AUC(0-24)md,u of elinzanetant
    AUC: Area under the curve extrapolated to infinity. AUC(0-24)md,u: AUC from time 0 to 24 after multiple dosing of the unbound analyte.
    date_rangeTime Frame:
    On day 8

Secondary Outcome

  • Incidence of treatmentemergent adverse events (TEAEs)
    date_rangeTime Frame:
    About 10 months
  • Severity of treatmentemergent adverse events (TEAEs)
    date_rangeTime Frame:
    About 10 months
  • AUCu of elinzanetant
    Or AUC(0-tlast) if AUC cannot be determined. AUCu: AUC extrapolated to infinity of the unbound analyte. AUC(0-tlast): AUC from time 0 to the last data point > LLOQ (lower limit of quantification)
    date_rangeTime Frame:
    On Day 1
  • Cmax,u of elinzanetant
    Cmax,u: Maximum observed drug concentration in measured matrix after single dose administration of the unbound analyte.
    date_rangeTime Frame:
    On Day 1

Trial design

Open-label study to evaluate the pharmacokinetics, safety and tolerability of elinzanetant in participants with impaired hepatic function (classified as Child-Pugh A or B) in comparison to matched controls with normal hepatic function.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Non-randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
4

Additional Information