Bioavailability, Safety and Tolerability of elinzanetant (BAY 3427080) in Healthy Adults for Treatment of Vasomotor Symptoms

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What is this study about?

The trial focuses on vasomotor symptoms, which are hot flashes and night sweats that can appear when sex hormone levels change in women and men. The investigational medicine being examined is elinzanetant, also known by the code name BAY 3427080, and it is taken by mouth as a tablet or a soft capsule.

The purpose of the study is to learn how much of the medicine reaches the bloodstream, how safe it is, and how well it is tolerated after a single dose taken on an empty stomach and after several doses taken after a light evening meal. Participants will receive each formulation in a fixed order, with a short break between them, and will stay in the clinic for monitoring and follow‑up visits. Simple explanations are provided for technical words: bioavailability means the amount of drug that gets into the blood, and tolerability refers to how comfortably the body handles the drug; any side effects that appear are recorded.

1 baseline assessment

after joining the study you will attend a baseline visit where basic health measurements are recorded.

you will be instructed to fast for at least eight hours before any dosing day.

2 single fasted dose of formulation a

on the first dosing day you will take one elinzanetant tablet containing 120 mg under a fasted condition (no food for at least eight hours).

the tablet is taken with a small amount of water.

blood samples will be collected at several time points after the dose to measure how much drug enters the blood.

3 washout period after formulation a

a short break without any study medication will follow to allow the drug to leave your system before the next single dose.

4 single fasted dose of formulation b

you will take one elinzanetant soft capsule containing 120 mg after an overnight fast.

the capsule is swallowed with water.

blood will again be drawn at several intervals to compare drug levels with the tablet formulation.

5 washout period after formulation b

another short break without medication will be observed before the next single dose.

6 single fasted dose of formulation c

you will take one elinzanetant tablet containing 120 mg under the same fasted conditions.

the tablet is taken with water and blood samples are collected to complete the single‑dose comparison.

7 washout period after formulation c

a final break without study medication will follow before the multiple‑dose phase begins.

8 multiple‑dose period with formulation a

you will take one 120 mg tablet of elinzanetant each day for fourteen consecutive days.

each dose is taken orally three hours after a light dinner.

blood samples will be collected on day 13, day 14 and day 15 to assess peak and trough drug levels.

9 washout period after formulation a multiple dosing

a break without medication will be required before starting the next formulation.

10 multiple‑dose period with formulation b

you will take one 120 mg soft capsule of elinzanetant each day for fourteen days.

the capsule is taken three hours after a light dinner, the same as the tablet schedule.

blood will be drawn on day 13, day 14 and day 15 to measure drug exposure.

11 washout period after formulation b multiple dosing

another medication‑free interval will be observed before the final formulation.

12 multiple‑dose period with formulation c

you will take one 120 mg tablet of elinzanetant daily for fourteen days, again three hours after a light dinner.

blood samples on day 13, day 14 and day 15 will complete the comparison of all three formulations.

13 final safety follow‑up

after the last dosing period you will attend a final visit where any side effects experienced during the study are recorded.

the study team will review the safety information before the study is closed.

Who Can Join the Study?

Male participants must be between 18 and 45 years old, and female participants must be between 18 and 55 years old, when they sign the informed consent (a document that shows they understand and agree to join the study).
All volunteers must be in good overall health, as judged by the study doctor. This includes a review of medical history, a physical check‑up, measurement of blood pressure (the force of blood against the walls of the arteries), checking the pulse rate (how fast the heart beats), a 12‑lead electrocardiogram (ECG) (a test that records the heart’s electrical activity), recording body temperature, and standard lab tests (blood and urine tests) to confirm health.

Who Cannot Join the Study?

Having any disease that could make the way the body absorbs (takes in), distributes (spreads), metabolizes (breaks down), eliminates (gets rid of), or reacts to the study medication not normal.
Using any prescription or over‑the‑counter medication, herbal product, or cream that works throughout the whole body (systemic) or on the skin (topical) within 2 weeks (or five times the drug’s half‑life, whichever is longer) before the first dose or at any time during the study, except occasional use of acetaminophen (paracetamol) or ibuprofen.
Having an abnormal result on the heart test called an electrocardiogram (ECG)—a test that records the heart’s electrical activity—such as a QRS complex (the part that shows the main heartbeats) over 120 ms or a QTcF (a measurement of the heart’s recovery time, adjusted for heart rate) over 450 ms at screening.
Having a systolic blood pressure (the top number that measures pressure when the heart beats) lower than 90 mmHg or higher than 140 mmHg during screening or the day before the first dose.
Having a diastolic blood pressure (the bottom number that measures pressure when the heart rests) lower than 50 mmHg or higher than 90 mmHg during screening or the day before the first dose.
Having a pulse rate (heart beats per minute) lower than 45 or higher than 100 beats per minute at screening.
Having any safety laboratory test results (blood chemistry, blood cell counts, or urine tests) that are outside the normal reference ranges at screening, especially liver enzymes—such as AST, ALT, ALP, GGT, or total bilirubin—greater than 1.2 times the upper limit of normal (ULN), or a muscle enzyme called creatine kinase (CK) greater than 3 times the ULN.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Nlmkjbn Gdnd	Neu-Ulm	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	04.09.2023

Trial locations

Investigated Drugs:

Elinzanetant

Elinzanetant is an oral tablet that participants swallow. In this study it is being given to see how quickly and how much of the medicine enters the bloodstream when taken on an empty stomach. The researchers are checking its safety and how well participants tolerate it.

Elinzanetant is also provided as a soft capsule that is taken by mouth. This capsule form is compared with the tablet form to understand if the shape of the product changes how the body absorbs the medicine, and to monitor any side effects.

Elinzanetant besilate is an oral tablet that contains the besilate version of the same active ingredient. This formulation is tested alongside the other two to determine whether the different chemical form affects how the drug is absorbed, its safety, and how well participants tolerate it.

Investigated Diseases:

Vasomotor symptoms – Vasomotor symptoms are sudden feelings of heat, often accompanied by sweating and reddening of the skin. They commonly occur when the body’s sex hormone levels change, such as during menopause in women or androgen decline in men. Episodes may start occasionally and become more frequent or intense over weeks to months. The symptoms can affect daily activities, especially when they happen at night and disturb sleep. Their pattern often varies from person to person, with some experiencing brief flashes and others longer periods of warmth. Over time, the frequency and severity may fluctuate, sometimes decreasing as the body adapts to the hormonal shift.

Trial ID:

2023-503864-17-00

Protocol code:

22382

Trial Phase:

Human Pharmacology (Phase I) – Other

Other Trials to Consider

Bioavailability, Safety and Tolerability of elinzanetant (BAY 3427080) in Healthy Adults for Treatment of Vasomotor Symptoms