Clinical trial NCT05351892: A Study to Learn More About How Much of the Study Treatment Elinzanetant (or BAY3427080) Gets Absorbed, How Safe it is and How it Affects the Body in Healthy Female and Male Participants
Official title: A Combined Single- and Multiple-dose, Open-label, Randomized, 2 x 2 Crossover Study to Investigate the Relative Bioavailability, the Safety and the Tolerability of Elinzanetant (BAY 3427080) in Healthy Female and Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men
Hot Flashes
Healthy Volunteers
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2022-04-28
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Researchers are looking for a better way to treat men and women with vasomotor symptoms, a condition of having hot flashes caused by hormonal changes.

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 elinzanetant in people with vasomotor symptoms.

In previous studies, capsules containing smaller amounts of elinzanetant have been used. To reach the daily dose intended for treatment, 3 of these capsules had to be taken once a day. To reduce the pill burden and make it easier for patients to stick to the treatment, capsules with a higher amount of elinzanetant have been developed.

The main purpose of this study is to learn how much of the study treatment elinzanetant gets into the participants' blood when the same dose is taken as new capsule formulation compared to the old capsule formulation.

To answer this question, the researchers will compare:

* The (average) total level of elinzanetant in the blood (also called AUC)
* The (average) highest level of elinzanetant in the blood (also called Cmax) between both capsule formulations after taking one dose of each.

In addition, the researchers want to compare how much of the new and old elinzanetant formulations get into the blood after intake for 9 subsequent days.

All participants will take both formulations by mouth during the study. Each participant will be in the study for up to 12 weeks, including 10 treatment days for each formulation. Participants will stay in-house for 14 days per capsule formulation. In addition, one screening visit to the study site is planned.

During the study, the study doctor and their team will:

* Do physical examinations
* Take blood and urine samples
* Check vital signs
* Examine the participants' heart health using electrocardiogram (ECG)
* Ask the participants questions about how they are feeling and what adverse events they are having.

An adverse event is any medical problem that a participant has during a study. The study doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.


Eligibility criteria: Inclusion Criteria:

* Participant must be 18 to 45 years of age inclusive, at the time of signing the informed consent.
* Participants who are overtly healthy as determined by medical evaluation of the investigator, including medical history, physical examination, blood pressure, pulse rate, body temperature, laboratory tests, and cardiac monitoring
* Body weight of at least 50 kg and body mass index (BMI) within the range 18 to 30 kg/m\^2 (inclusive)
* Male or female
* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

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 elinzanetant or any of their excipients
* Any history of or ongoing endocrine disease
* Any known impairment of testosterone synthesis and metabolism
* Poor venous access
* History of alcohol or drug abuse
* Regular use of prescription drugs, over-the-counter drugs, supplements (e.g. carnitine products, anabolics, high dose vitamins) or herbal products within 2 weeks or 5 half-lives (whichever longer) prior to the first study intervention administration
* Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them within 4 weeks prior to the first study intervention administration, e.g. any investigational drug, any CYP3A4 inducers including St John's Wort, any proton pump inhibitors, or any other drug known to induce liver enzymes (e.g. dexamethasone, barbiturates), and 2 weeks for any drug known to inhibit liver enzymes (e.g. itraconazole, macrolides) as well as grapefruit.
* Clinically relevant findings in the Electrocardiogram (ECG), such as second or third degree AV block, prolongation of ECG parameters (QTcF \> 450 msec, QRS \> 120 msec)
* Clinically relevant deviations of the screened laboratory parameters from reference ranges at screening or Day -1.

Primary outcomes:
measure: Area under the concentration versus time curve from zero to infinity of elinzanetant after single dose administration (AUC)
timeFrame: 0 to 84 hours after first dose on Study Day 1
measure: Maximum observed drug concentration of elinzanetant in plasma after single dose administration (Cmax)
timeFrame: 0 to 84 hours after first dose on Study Day 1
Secondary outcomes:
measure: Area under the concentration versus time curve from administration of last dose until 24 hours after last dose of multiple dosing (AUC[0-24]md)
timeFrame: 0 to 24 hours post-dose on Study Day 12/13
measure: Maximum observed drug concentration of elinzanetant in plasma after multiple dose administration (Cmax,md)
timeFrame: 0 to 24 hours post-dose on Study Day 12/13
measure: Observed drug concentration of elinzanetant in plasma prior to next dose administration (Ctrough)
timeFrame: 0 to 24 hours post-dose on Study Day 12/13
measure: Number of participants with treatment-emergent adverse events (TEAEs)
timeFrame: After first administration of study intervention until follow up (Day 14 of Period 2)
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami, LLC
state: Florida
Study officials:
References: