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Neurokinin Antagonist

Treatment B-A for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 to 24 hours post-dose on study day 12/13
Awards & highlights

Study 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.

Eligible Conditions
  • Hormone Imbalance Syndrome
  • Healthy Subjects
  • Hot Flashes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 to 24 hours post-dose on study day 12/13
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 to 24 hours post-dose on study day 12/13 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the concentration versus time curve from zero to infinity of elinzanetant after single dose administration (AUC)
Maximum observed drug concentration of elinzanetant in plasma after single dose administration (Cmax)
Secondary outcome measures
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)
Maximum observed drug concentration of elinzanetant in plasma after multiple dose administration (Cmax,md)
Number of participants with treatment-emergent adverse events (TEAEs)
+1 more

Side effects data

From 2019 Phase 2 trial • 199 Patients • NCT03596762
12%
Diarrhoea
12%
Nausea
12%
Herpes zoster
12%
Headache
6%
Bradycardia
6%
Fatigue
6%
Nephrolithiasis
6%
Abdominal pain upper
6%
Aspartate aminotransferase increased
6%
Rash
6%
Haematuria
6%
Flatulence
6%
Non-cardiac chest pain
6%
Viral upper respiratory tract infection
6%
Viral sinusitis
6%
Blood creatine phosphokinase increased
6%
Electrocardiogram QT prolonged
6%
Liver function test increased
6%
Joint swelling
6%
Somnolence
6%
Depressed mood
6%
Insomnia
6%
Breast tenderness
6%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
80 mg Elinzanetant (BAY3427080)
120 mg Elinzanetant (BAY3427080)
Placebo
40 mg Elinzanetant (BAY3427080)
160 mg Elinzanetant (BAY3427080)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment B-AExperimental Treatment1 Intervention
Participants will receive a single dose of elinzanetant supplied in strength level 2 and 9 subsequent multiple doses from Days 4 to 12 of Period 1; followed by a single dose of elinzanetant supplied in strength level 1 and 9 subsequent multiple doses from Days 4 to 12 of Period 2.
Group II: Treatment A-BExperimental Treatment1 Intervention
Participants will receive a single dose of elinzanetant supplied in strength level 1 and 9 subsequent multiple doses from Days 4 to 12 of Period 1; followed by a single dose of elinzanetant supplied in strength level 2 and 9 subsequent multiple doses from Days 4 to 12 of Period 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elinzanetant (BAY3427080)
2022
Completed Phase 3
~1870

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

BayerLead Sponsor
2,237 Previous Clinical Trials
25,326,960 Total Patients Enrolled

Frequently Asked Questions

~6 spots leftby Apr 2025