Vasomotor Symptoms
Conditions
Brief summary
The aim of this study is to examine the relative bioavailability of elinzanetant when administered in new oral formulations (treatment B and C) after both single and multiple oral doses, compared to its administration in soft gel capsule form (treatment A). Study details include: An ambulatory screening visit within 4 weeks prior to first treatment. Participants will be admitted to the ward on Day -1 of each period. On Day 1, either treatment B or treatment C will be administered fasted in the evening, followed by blood sampling for a 24-hour pharmacokinetic (PK) profile. On Day 2, the multiple dosing starts 3 hours after a standardized dinner in the evening. After the last dosing on Day 7, a complete PK profile for 24 hours will be collected. If there are no medical objections, participants will be discharged from the study ward on Day 9 in the morning for a washout-out period of at least 10 days (240 hours after last dosing, after period 1 and 2) or, in period 3, after the follow-up examination. The total duration of the study will be approximately 10 to 12 weeks for each participant.
Interventions
DRUGTreatment A
Elinzanetant (BAY 3427080), dosage 1
DRUGTreatment B
Elinzanetant (BAY 3427080), dosage 2
DRUGTreatment C
Elinzanetant (BAY 3427080), dosage 3
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Female participant between 18 to 65 years of age (inclusive), at the time of signing the informed consent form (ICF). * Participant is overtly healthy as determined by the investigator (including assessment of medical history, physical examination, blood pressure (BP), pulse rate, 12-lead electrocardiogram (ECG), body temperature, and clinical laboratory). * Body weight of at least 50 kg and body mass index (BMI) above or equal to 18.0 and below or equal to 32.0 kg/m² at screening. * Signed informed consent as described in Section 10.1.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
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 any study intervention (active substances or excipients of the preparations) to be used in the study - including e.g. non-investigational medicinal products, challenge agents, or rescue medication. * Febrile illness within 2 weeks before the start of the first study intervention. * History of clinically relevant seizures. * Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), Bilirubin, or gamma-glutamyl transferase (GGT) \> 1.2 x upper limit of normal (ULN). * Previous (within 30 days before first administration of study intervention) or concomitant participation in another clinical study with study intervention(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC(0-24)md after multiple oral dosing 3 h after light dinner in the evening (treatments A, B, C) | From Day 0 to Day 8 |
| Cmax,md and Cmin,,md after multiple oral dosing 3 h after light dinner in the evening (treatments A, B, C) | From Day 0 to Day 8 |
Secondary
| Measure | Time frame |
|---|---|
| AUC(0-24) after single dose in the evening under fasted condition (treatments A, B, C). | From Day 0 to Day 8 |
| Cmax after single dose in the evening under fasted condition (treatments A, B, C). | From Day 0 to Day 8 |
| Number and severity of treatment-emergent adverse events (TEAEs) after first study intervention until follow up | From first dosing up to Day 9 |
Countries
Canada
Outcome results
None listed