Completed

A Randomized, Double-blind, Placebo- and Moxifloxacin-controlled Study to Investigate the Safety and Pharmacokinetics of Single Ascending Supratherapeutic Doses of Elinzanetant in Healthy Participants

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What is being tested

Moxifloxacin

+ Placebo

+ Elinzanetant (BAY3427080)

Drug
Who is being recruted

Endocrine System Diseases+10

+ Endocrine Gland Neoplasms

+ Congenital, Hereditary, and Neonatal Diseases and Abnormalities

From 18 to 55 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Phase 1
Interventional
Study Start: August 2022
See protocol details

Summary

Principal SponsorBayer
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 19, 2022

Actual date on which the first participant was enrolled.

Researchers are looking for a better way to treat vasomotor symptoms, a condition of having hot flashes. The condition is caused by hormonal changes and occurs primarily in women, but can also affect men. The study treatment, elinzanetant, is under development to treat symptoms caused by hormonal changes. It works by blocking a substance called neurokinin from sending signals to other parts of the body, which is thought to play a role in starting hot flashes. Participants of this study will be healthy and will have no benefit from administration of elinzanetant. This study, however, will provide information on how to use it in people with vasomotor symptoms. In previous studies, elinzanetant doses tested and resulting blood levels were close to the levels intended for treatment. However, in future use, it cannot always be ruled out that higher elinzanetant concentrations may occur in the blood if patients are taking certain other drugs at the same time, or take more than the recommended dose of the drug. The main purpose of this study is to learn how safe elinzanetant is when higher doses than normally used are given compared to placebo in healthy participants. A placebo is a treatment that looks like a medicine but does not have any medicine in it. To answer this, researchers will compare the number of participants who have medical problems after taking elinzanetant to those treated with placebo. Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments. The study consists of two parts. In part 1, the participants will either take a single dose of elinzanetant or placebo by mouth dependent on the treatment group. Four different increasing doses of elinzanetant will be tested. Participants in dose group 1 and 4 will participate in part 2. About 8 days after treatment in part 1, the participants will receive a single dose of moxifloxacin and a single dose of placebo as tablet by mouth 5 days apart. Whether the participant starts with moxifloxacin or placebo is decided by chance. Moxifloxacin is used to make sure that certain changes in heart rhythm can be detected in the study. Each participant will be in the study for about 6 weeks including 1 treatment day (part 1) or for about 8 weeks including 3 treatment days (part 1 \& 2). Participants of part 1 will stay in-house for 7 days. Participants of part 2 will stay in-house for another 9 days. The in-house phase starts two days before intake of the study treatment. In addition, one visit before and one visit after the in-house phase to the study site is planned. During the study, the study team will: * Do physical examinations * Check vital signs * Take blood and urine samples * Examine the participants' heart health using electrocardiogram (ECG) * Ask the participants questions about their mood and about sleepiness.

Official TitleA Randomized, Double-blind, Placebo- and Moxifloxacin-controlled Study to Investigate the Safety and Pharmacokinetics of Single Ascending Supratherapeutic Doses of Elinzanetant in Healthy Participants
NCT05481528
Principal SponsorBayer
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

51 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Endocrine System DiseasesEndocrine Gland NeoplasmsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeoplasmsNeoplasms by SiteMultiple Endocrine NeoplasiaNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditarySigns and SymptomsPathological Conditions, Signs and SymptomsMultiple Endocrine Neoplasia Type 1Hot FlashesGenetic Diseases, Inborn

Criteria

5 inclusion criteria required to participate
Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, blood pressure, pulse rate, respiratory rate, body temperature and electrocardiogram (ECG).

Body weight of at least 50 kg.

Body mass index (BMI) within the range 18.0 to 30.0 kg/m^2 (inclusive).

Male subjects of reproductive potential must agree to use a condom (with or without spermicide) when sexually active with a female partner and refrain from donating sperm. This applies for the time period between the signing of the informed consent form (ICF) until 5 days after the last administration of study intervention. Female partners of childbearing potential of male subjects do not need to follow special precautions.

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10 exclusion criteria prevent from participating
Any clinically relevant abnormal findings in medical history and physical examination. Including: History or evidence of any clinically relevant cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other clinically relevant disease, as judged by the investigator; Diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention will not be normal.

Known or suspected hypersensitivity or allergy to the study interventions or other fluoroquinolone products.

Relevant diseases within the last 4 weeks prior to the first administration of study intervention, including febrile illness.

Contraindications for the use of moxifloxacin, including: Medical history of seizures or psychiatric disorders, myasthenia gravis, severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN; also known as Lyell's syndrome), Stevens Johnson syndrome (SJS) and Acute Generalized Exanthematous Pustulosis (AGEP), glucose-6-phosphate dehydrogenase deficiency.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

6 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants of Dose Groups 1 and 4 will receive a single dose of moxifloxacin in Period 1 and a single dose of placebo in Period 2.

Group II

Experimental
Participants of Dose Groups 1 and 4 will receive a single dose of placebo in Period 1 and a single dose of moxifloxacin in Period 2.

Group III

Experimental
Single oral dose of elinzanetant or placebo.

Group IV

Experimental
Single oral dose of elinzanetant or placebo

Group 5

Experimental
Single oral dose of elinzanetant or placebo

Group 6

Experimental
Single oral dose of elinzanetant or placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

NUVISAN GmbH Neu-Ulm

Neu-Ulm, GermanyOpen NUVISAN GmbH Neu-Ulm in Google Maps
CompletedOne Study Center