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

NCT07229404 | Completed Phase 1 DMC

• 1 other identifier: 22790
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vasomotor Symptoms

Outcome Measures

Primary Outcomes (2)

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

  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)

  From Day 0 to Day 8

Secondary Outcomes (3)

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

  From Day 0 to Day 8

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

  From Day 0 to Day 8

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

  From first dosing up to Day 9

Study Arms (6)

Sequence 1

EXPERIMENTAL

Treatments are administered in sequence of A-B-C

Drug: Treatment A; Drug: Treatment B; Drug: Treatment C

Sequence 2

EXPERIMENTAL

Treatments are administered in sequence of A-C-B

Drug: Treatment A; Drug: Treatment B; Drug: Treatment C

Sequence 3

EXPERIMENTAL

Treatments are administered in sequence of C-A-B

Drug: Treatment A; Drug: Treatment B; Drug: Treatment C

Sequence 4

EXPERIMENTAL

Treatments are administered in sequence of C-B-A

Drug: Treatment A; Drug: Treatment B; Drug: Treatment C

Sequence 5

EXPERIMENTAL

Treatments are administered in sequence of B-C-A

Drug: Treatment A; Drug: Treatment B; Drug: Treatment C

Sequence 6

EXPERIMENTAL

Treatments are administered in sequence of B-A-C

Drug: Treatment A; Drug: Treatment B; Drug: Treatment C

Interventions

Treatment A DRUG

Elinzanetant (BAY 3427080), dosage 1

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Treatment B DRUG

Elinzanetant (BAY 3427080), dosage 2

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Treatment C DRUG

Elinzanetant (BAY 3427080), dosage 3

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Altasciences

Mount Royal, Quebec, H3P 3P1, Canada

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: November 5, 2025
• Primary Completion: January 14, 2026
• Study Completion: January 14, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)