Skip to main content
OpenTrials
Completed

NCT Number: NCT07229404

A Study to Investigate Relative Bioavailability, Safety and Tolerability of Single- and Multiple-doses of Elinzanetant in Healthy Female Participants

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences

Mount Royal, Quebec, H3P 3P1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Treatment A

Drug

Elinzanetant (BAY 3427080), dosage 1

Treatment B

Drug

Elinzanetant (BAY 3427080), dosage 2

Treatment C

Drug

Elinzanetant (BAY 3427080), dosage 3

Primary outcomes

  1. AUC(0-24)md after multiple oral dosing 3 h after light dinner in the evening (treatments A, B, C)

    Time frame: From Day 0 to Day 8

  2. Cmax,md and Cmin,,md after multiple oral dosing 3 h after light dinner in the evening (treatments A, B, C)

    Time frame: From Day 0 to Day 8

Secondary outcomes

  1. AUC(0-24) after single dose in the evening under fasted condition (treatments A, B, C).

    Time frame: From Day 0 to Day 8

  2. Cmax after single dose in the evening under fasted condition (treatments A, B, C).

    Time frame: From Day 0 to Day 8

  3. Number and severity of treatment-emergent adverse events (TEAEs) after first study intervention until follow up

    Time frame: From first dosing up to Day 9

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 17, 2025
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.