do_not_disturb_altRecruitment Complete

Vasomotor Symptoms

Bayer Identifier:
22790
ClinicalTrials.gov Identifier:
NCT07229404
EudraCT Number:
Not Available
EU CT Number:
Not Available
A study to investigate relative bioavailability, safety and tolerability of single- and multiple-doses of elinzanetant in healthy female participants

Trial purpose

The aim of this study is to examine the relative bioavailability of elinzanetant when administered in new oral formulations (treatment B and C) after both single and multiple oral doses, compared to its administration in soft gel capsule form (treatment A).

Study details include:
An ambulatory screening visit within 4 weeks prior to first treatment.
Participants will be admitted to the ward on Day -1 of each period.
On Day 1, either treatment B or treatment C will be administered fasted in the evening, followed by blood sampling for a 24-hour pharmacokinetic (PK) profile.
On Day 2, the multiple dosing starts 3 hours after a standardized dinner in the evening.
After the last dosing on Day 7, a complete PK profile for 24 hours will be collected.
If there are no medical objections, participants will be discharged from the study ward on Day 9 in the morning for a washout-out period of at least 10 days (240 hours after last dosing, after period 1 and 2) or, in period 3, after the follow-up examination.
The total duration of the study will be approximately 10 to 12 weeks for each participant.

Key Participants Requirements

Sex

Female

Age

18 - 65 Years
    - Female participant between 18 to 65 years of age (inclusive), at the time of signing the informed consent form (ICF).
    - Participant is overtly healthy as determined by the investigator (including assessment of medical history, physical examination, blood pressure (BP), pulse rate, 12-lead electrocardiogram (ECG), body temperature, and clinical laboratory).
    - Body weight of at least 50 kg and body mass index (BMI) above or equal to 18.0 and below or equal to 32.0 kg/m² at screening.
    - Signed informed consent as described in Section 10.1.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    - Diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study intervention(s) will not be normal.
    - Known or suspected allergy or hypersensitivity to any study intervention (active substances or excipients of the preparations) to be used in the study – including e.g. non-investigational medicinal products, challenge agents, or rescue medication.
    - Febrile illness within 2 weeks before the start of the first study intervention.
    - History of clinically relevant seizures.
    - Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), Bilirubin, or gamma-glutamyl transferase (GGT) > 1.2 x upper limit of normal (ULN).
    - Previous (within 30 days before first administration of study intervention) or concomitant participation in another clinical study with study intervention(s).

Trial summary

Enrollment Goal
16
Trial Dates
November 2025 - January 2026
Phase
Phase 1
Could I Receive a placebo
No
Products
Lynkuet (Elinzanetant, BAY3427080)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Active, not recruiting
AltasciencesMount-Royal, H3P 3P1, Canada

Primary Outcome

  • AUC(0-24)md after multiple oral dosing 3 h after light dinner in the evening (treatments A, B, C)
    date_rangeTime Frame:
    From Day 0 to Day 8
  • Cmax,md and Cmin,,md after multiple oral dosing 3 h after light dinner in the evening (treatments A, B, C)
    date_rangeTime Frame:
    From Day 0 to Day 8

Secondary Outcome

  • AUC(0-24) after single dose in the evening under fasted condition (treatments A, B, C).
    date_rangeTime Frame:
    From Day 0 to Day 8
  • Cmax after single dose in the evening under fasted condition (treatments A, B, C).
    date_rangeTime Frame:
    From Day 0 to Day 8
  • Number and severity of treatment-emergent adverse events (TEAEs) after first study intervention until follow up
    date_rangeTime Frame:
    From first dosing up to Day 9

Trial design

A combined single- and multiple-dose, open-label, randomized, 6 x 3 crossover study to investigate the relative bioavailability, safety and tolerability of elinzanetant (BAY 3427080) in healthy female participants
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Crossover Assignment
Trial Arms
6