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

COMPLETEDPHASE1

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

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

NCT07229404•Bayer

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 65 years

Sex

FEMALE

Healthy Volunteers

Yes

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).

Locations (1)

Altasciences

Mount Royal, Quebec, Canada

Key Dates

Start Date

November 5, 2025

Primary Completion Date

January 14, 2026

Completion Date

January 14, 2026

Last Updated

January 27, 2026

Enrollment

ACTUAL participants

Conditions

Vasomotor Symptoms

Interventions

Treatment A

DRUG

Treatment B

DRUG

Treatment C

DRUG

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PerimenopausePerimenopausal Depression+6 more

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COMPLETEDPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Trial to Investigate the Accuracy of a Wearable Device in Collecting Data Related to Perimenopausal Symptoms in Women

Long-term Safety and Efficacy Study of MT-8554 in Postmenopausal Women With Vasomotor Symptoms

Stellate Ganglion Blockade in Post-Menopausal Women

Evaluation of the Pharmacokinetics and Safety of BAY3427080 (NT-814) in Post-Menopausal Women With Vasomotor Symptoms

A Survey About Trade-offs When Choosing Menopause Treatments

A Study to Learn if Elinzanetant Affects the Ability to Drive and Brain Function in Healthy Women