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

NCT ID: NCT07229404

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-05

Study Completion Date

2026-01-21

Brief Summary

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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.

Detailed Description

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Conditions

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Vasomotor Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence 1

Treatments are administered in sequence of A-B-C

Group Type EXPERIMENTAL

Treatment A

Intervention Type DRUG

Elinzanetant (BAY 3427080), dosage 1

Treatment B

Intervention Type DRUG

Elinzanetant (BAY 3427080), dosage 2

Treatment C

Intervention Type DRUG

Elinzanetant (BAY 3427080), dosage 3

Sequence 2

Treatments are administered in sequence of A-C-B

Group Type EXPERIMENTAL

Treatment A

Intervention Type DRUG

Elinzanetant (BAY 3427080), dosage 1

Treatment B

Intervention Type DRUG

Elinzanetant (BAY 3427080), dosage 2

Treatment C

Intervention Type DRUG

Elinzanetant (BAY 3427080), dosage 3

Sequence 3

Treatments are administered in sequence of C-A-B

Group Type EXPERIMENTAL

Treatment A

Intervention Type DRUG

Elinzanetant (BAY 3427080), dosage 1

Treatment B

Intervention Type DRUG

Elinzanetant (BAY 3427080), dosage 2

Treatment C

Intervention Type DRUG

Elinzanetant (BAY 3427080), dosage 3

Sequence 4

Treatments are administered in sequence of C-B-A

Group Type EXPERIMENTAL

Treatment A

Intervention Type DRUG

Elinzanetant (BAY 3427080), dosage 1

Treatment B

Intervention Type DRUG

Elinzanetant (BAY 3427080), dosage 2

Treatment C

Intervention Type DRUG

Elinzanetant (BAY 3427080), dosage 3

Sequence 5

Treatments are administered in sequence of B-C-A

Group Type EXPERIMENTAL

Treatment A

Intervention Type DRUG

Elinzanetant (BAY 3427080), dosage 1

Treatment B

Intervention Type DRUG

Elinzanetant (BAY 3427080), dosage 2

Treatment C

Intervention Type DRUG

Elinzanetant (BAY 3427080), dosage 3

Sequence 6

Treatments are administered in sequence of B-A-C

Group Type EXPERIMENTAL

Treatment A

Intervention Type DRUG

Elinzanetant (BAY 3427080), dosage 1

Treatment B

Intervention Type DRUG

Elinzanetant (BAY 3427080), dosage 2

Treatment C

Intervention Type DRUG

Elinzanetant (BAY 3427080), dosage 3

Interventions

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Treatment A

Elinzanetant (BAY 3427080), dosage 1

Intervention Type DRUG

Treatment B

Elinzanetant (BAY 3427080), dosage 2

Intervention Type DRUG

Treatment C

Elinzanetant (BAY 3427080), dosage 3

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Altasciences

Mount Royal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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22790

Identifier Type: -

Identifier Source: org_study_id