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Relative bioavailability and safety of elinzanetant soft‑gel capsules in healthy adults for vasomotor symptoms

Investigational
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study looks at a condition called vasomotor symptoms, which are hot flashes and night sweats that can happen when sex hormones change in women and men. The medication being examined is an oral pill that contains the active ingredient elinzanetant, also known by its code name BAY 3427080, and it is provided in a soft gel capsule form.

The purpose of the study is to compare how much of the medication is absorbed into the bloodstream from different capsule formulations. Participants will take a single dose of each capsule type while fasting, meaning they will not eat for several hours before taking the medicine, and the study will follow a simple schedule where each dose is given at separate times.

Researchers will watch for any adverse events, which are side effects or unwanted reactions, and will record how often they occur and how severe they are, while also measuring how much of the drug reaches the blood to understand its bioavailability.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    First study visit and initial dose

    You arrive at the study site after an overnight fast. fasting means you have not eaten or drunk anything except water for at least 8 hours before the visit.

    Baseline measurements such as weight, blood pressure, and a brief health questionnaire are recorded.

    You are given one soft gel capsule containing 120 mg of elinzanetant. the capsule is taken by mouth with a small sip of water.

    This is a single dose administered under fasting conditions.

  2. Step 2

    Blood sampling after the first dose

    Following the dose, a series of blood samples are taken at several time points over the next several hours. these samples are used to measure how much elinzanetant enters your bloodstream.

    You remain at the clinic during this period and may be asked to report any feeling of discomfort or other symptoms.

  3. Step 3

    Safety monitoring after the first dose

    Study staff observe you for any adverse events, which are any unwanted signs, symptoms, or medical problems that may occur after taking the medication.

    If any symptoms appear, they are recorded and evaluated for severity.

  4. Step 4

    Washout period

    After the first dosing period, you will have a break before receiving the next formulation. the length of this break is decided by the study protocol to ensure the previous dose is fully cleared from your body.

  5. Step 5

    Second study visit and second dose

    You return to the study site after the washout period, again after an overnight fast.

    Baseline checks are repeated, and you receive a second soft gel capsule containing 120 mg of elinzanetant. this capsule is a different formulation from the first one, but the dose and fasting conditions are the same.

  6. Step 6

    Blood sampling after the second dose

    As with the first dose, multiple blood samples are collected over several hours to assess how the second formulation is absorbed.

    You stay at the clinic during the sampling period and continue to report any symptoms.

  7. Step 7

    Final safety assessment

    After the second dosing period, study staff perform a final check for any adverse events and complete the study questionnaires.

    The collected data will be used to compare the absorption and safety of the two formulations.

Who can join the trial?

2 criteria

  • Be between 18 and 55 years old when you sign the informed consent (your written agreement after learning about the study).
  • Be clearly healthy as judged by a medical check that includes a review of your medical history (your past health record), a physical examination (doctor looks at your body), measurements of blood pressure (pressure of blood in your vessels), pulse rate (heart beats per minute), body temperature (how hot you are), a 12‑lead ECG (a test that records the heart’s electrical activity using 12 sensors), and laboratory tests (blood or urine tests).

Who cannot join the trial?

4 criteria

  • Pregnant or breastfeeding women cannot join the study.
  • People who have a medical condition (any illness) or a personal or family history of illness that the doctor believes could make it difficult to take part in or finish the study. This includes inherited (family) diseases and past illnesses that might still affect you.
  • Anyone with a disease that could change how the body absorbs (takes in), distributes (spreads), metabolizes (breaks down), or eliminates (gets rid of) the medicine being tested.
  • People who regularly use prescription drugs, over‑the‑counter drugs (medicines you can buy without a prescription), supplements such as carnitine products, anabolic agents, high‑dose vitamins, or any herbal products.
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Investigated drugs

  • Elinzanetant Bayer

    is an oral soft‑gel capsule that contains the experimental drug elinzanetant. In this study the capsule is given as a single dose to healthy volunteers while they are fasting. The purpose is to see how much of the drug is absorbed into the bloodstream compared with other capsule formulations.

  • BAY 3427080

    is another name for the same experimental drug, elinzanetant, also provided in a soft‑gel capsule taken by mouth. This version is tested alongside the Bayer capsule to compare how well the body absorbs the medication when given under the same fasting conditions.

What is already known about the treatment

Elinzanetant - Elinzanetant is taken as a soft‑gel capsule taken by mouth, usually once with an empty stomach. It is currently an investigational drug that has reached Phase 3 trials and is described in recent medical literature as a potential treatment for hot flashes and other vasomotor symptoms in men and women. The medicine works by blocking two types of neurokinin receptors (NK1 and NK3), which helps to reduce the hormonal signals that cause sudden temperature spikes. It belongs to the class of neurokinin receptor antagonists.

Investigated diseases

Vasomotor symptoms - These are episodes of sudden heat, flushing, and sweating that are linked to changes in sex hormone levels. They commonly appear during periods of hormonal transition such as menopause in women and age‑related hormonal decline in men. The symptoms often start mildly and can become more frequent or intense over time. They may occur during the day or night, sometimes disrupting sleep. The pattern of episodes can vary from person to person, with some experiencing occasional events and others having daily occurrences. The condition usually progresses gradually as hormonal fluctuations continue.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-503968-16-00Protocol code22424Estimated enrolment16 patientsSponsorBayer AG

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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