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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Elinzanetant (BAY 3427080), dosage 1
Elinzanetant (BAY 3427080), dosage 2
Elinzanetant (BAY 3427080), dosage 3
Altasciences
Mount Royal, Quebec, Canada
AUC(0-24)md after multiple oral dosing 3 h after light dinner in the evening (treatments A, B, C)
Time frame: 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)
Time frame: From Day 0 to Day 8
AUC(0-24) after single dose in the evening under fasted condition (treatments A, B, C).
Time frame: From Day 0 to Day 8
Cmax after single dose in the evening under fasted condition (treatments A, B, C).
Time frame: From Day 0 to Day 8
Number and severity of treatment-emergent adverse events (TEAEs) after first study intervention until follow up
Time frame: From first dosing up to Day 9
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