NCT07229404

A Study to Investigate Relative Bioavailability, Safety and Tolerability of Single- and Multiple-doses of Elinzanetant in Healthy Female Participants

A Combined Single- and Multiple-dose, Open-label, Randomized, 6 x 3 Crossover Study to Investigate the Relative Bioavailability, Safety and Tolerability of Elinzanetant (BAY 3427080) in Healthy Female Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vasomotor Symptoms

Interventions

Type	Name	Description
DRUG	Treatment A	Elinzanetant (BAY 3427080), dosage 1
DRUG	Treatment B	Elinzanetant (BAY 3427080), dosage 2
DRUG	Treatment C	Elinzanetant (BAY 3427080), dosage 3

Timeline

• Start date: 2025-11-05
• Primary completion: 2026-01-14
• Completion: 2026-01-14
• First posted: 2025-11-17
• Last updated: 2026-01-27

Locations

1 site across 1 country: Canada