Comparison of the Extent to Which the Drug Given as Two Different Capsule Sizes Becomes Available to the Body

Sponsor
Bayer
Study ID
NCT04845841
Phase
PHASE1
Status
Completed

Conditions

  • Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Elinzanetant (BAY3427080) treatment A — DRUG
    Single oral dose
  • Elinzanetant (BAY3427080) treatment B — DRUG
    Single oral dose

Study Details

Researchers are looking for a new way to treat women who have symptoms by hormonal changes, like those that happen in women during menopause. These symptoms can include hot flashes, night sweats, and changes in blood pressure. These symptoms are caused by hormonal changes occurring during menopausal transition when women may have also changes in their monthly cycles. The menopausal transition most often begins between ages 45 and 55 and leads to menopause, a point in time 12 months after a woman's last period. The study drug, elinzanetant, was designed to treat symptoms caused by hormonal changes. Before a new treatment can be approved for people to take, researchers perform clinical trials to better understand how this treatment works and to investigate safety. The purpose of this study is to assess the blood levels of elinzanetant when given as 2 capsules of dose A (what is intended for further research and future commercialization) and also to compare the blood levels when given as 3 capsules of dose B (what was used for research up to now). Furthermore, researchers want to find out if taking of elinzanetant on two time points leads to differences in blood levels of elinzanetant. This trial will be performed in healthy women aged 40 to 65 years.

Key Dates

First listed
Apr 15, 2021
Start date
Apr 9, 2021
Status verified
Aug 2023
Primary completion
Jun 1, 2021
Completion
Jun 1, 2021

Study Design

Enrollment
16 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Participants receive study medication on time point 1
    Participants will receive two single doses of elinzanetant in two different treatments in a randomized sequence (Treatment A, Treatment B).
  • Experimental: Participants receive study medication on time point 2
    Participants will receive two single doses of elinzanetant in two different treatments in a randomized sequence (Treatment A, Treatment B).

Primary Outcome Measure

AUC of elinzanetant [ Time Frame: Period 1: Day 1-9, Day 11, Day 13, Day 15; Period 2: Day 1-7, Day 8 (follow up visit) ]

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