A Combined Single- and Multiple-dose, Open-label, Randomized, 2 x 2 Crossover Study to Investigate the Relative Bioavailability of Two Oral Elinzanetant (BAY 3427080) Formulations in Healthy Female Participants
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Area Under the Plasma Concentration-Time Curve Over 24 Hours After Multiple Dosing (AUC(0-24)md)
Study Overview
Brief Summary
This study is being done to compare two forms of the medicine elinzanetant, which is used to help manage hot flush symptoms related to changes in female hormones. The researchers want to find out whether a new tablet form of elinzanetant is absorbed and processed by the body of healthy women in a similar way than an existing capsule form.
About 100 healthy women aged 18 to 65 will take part in this study. Each participant will receive both forms of the medicine at different times during the study. They will take the medicine once daily for several days under controlled conditions at a study center, and blood samples will be collected to measure how the body absorbs and handles the drug. The study is designed so that each participant can be compared to herself, helping researchers clearly understand any differences between the two formulations.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Female participants aged 18 to 65 years (inclusive) at the time of signing informed consent.
- •Participants must be overtly healthy as determined by the investigator based on medical history, physical examination, vital signs, ECG, and clinical laboratory assessments.
- •Body weight ≥50 kg and body mass index (BMI) between 18.0 and 32.0 kg/m² (inclusive) at screening.
- •Women of childbearing potential must agree to use a highly effective method of contraception during the study and until 14 days after last administration of study intervention.
- •Signed informed consent obtained prior to any study-specific procedures.
Exclusion Criteria
- •Diseases or conditions that may affect absorption, distribution, metabolism, elimination, or effects of the study intervention(s).
- •Known or suspected hypersensitivity to the study intervention(s) or their excipients.
- •Severe allergies or clinically significant hypersensitivity reactions (e.g. allergic asthma, urticaria, or steroid-requiring allergies).
- •Febrile illness within 2 weeks prior to first administration of study intervention.
- •History of clinically relevant seizures or endometrial tumors.
- •Use of moderate or strong CYP3A4 inhibitors or inducers within 4 weeks prior to first study intervention.
- •Participation in another clinical study within 30 days prior to first study intervention or concurrent participation in another trial.
- •Clinically relevant abnormal laboratory findings at screening, including elevated liver enzymes or positive virology tests.
- •Positive pregnancy test at screening or prior to dosing, or breastfeeding. Positive drug abuse or alcohol test at screening.
- •Smoking more than 10 cigarettes per day within 3 months prior to screening.
- •Special diets incompatible with study requirements or inability to comply with study procedures.
Arms & Interventions
Sequence 1: Treatment A followed by Treatment B
Participants receive Treatment A followed by Treatment B in a randomized 2 x 2 crossover design with two treatment periods.
Intervention: Elinzanetant (BAY 3427080) treatment A (Drug)
Sequence 1: Treatment A followed by Treatment B
Participants receive Treatment A followed by Treatment B in a randomized 2 x 2 crossover design with two treatment periods.
Intervention: Elinzanetant (BAY 3427080) treatment B (Drug)
Sequence 2: Treatment B followed by Treatment A
Participants receive Treatment B followed by Treatment A in a randomized 2 x 2 crossover design with two treatment periods.
Intervention: Elinzanetant (BAY 3427080) treatment A (Drug)
Sequence 2: Treatment B followed by Treatment A
Participants receive Treatment B followed by Treatment A in a randomized 2 x 2 crossover design with two treatment periods.
Intervention: Elinzanetant (BAY 3427080) treatment B (Drug)
Outcomes
Primary Outcomes
Area Under the Plasma Concentration-Time Curve Over 24 Hours After Multiple Dosing (AUC(0-24)md)
Time Frame: On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)
elinzanetant administered in the evening 3 hours after a light dinner.
Maximum Observed Plasma Concentration After Multiple Dosing (Cmax,md)
Time Frame: On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)
elinzanetant administered in the evening 3 hours after a light dinner.
Minimum Observed Plasma Concentration During Dosing Interval After Multiple Dosing (Cmin,md)
Time Frame: On Day 11 of each 12-day treatment period (study intervention administered on Days 1-10)
elinzanetant administered in the evening 3 hours after a light dinner.
Secondary Outcomes
- Number and Severity of Treatment-Emergent Adverse Events (TEAEs)(From first dose of study intervention through Day 12 of Period 2 (each treatment period is 12 days))
- Area Under the Plasma Concentration-Time Curve Over 24 Hours After Single Dose (AUC(0-24))(On Day 2 of each 12-day treatment period)
- Maximum Observed Plasma Concentration After Single Dose (Cmax)(On Day 2 of each 12-day treatment period)