A Phase 1 interventional study of Treatment A and Treatment B in Vasomotor Symptoms, sponsored by Bayer. Completed at 1 site in Canada. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-27.
Sponsored by Bayer · Phase 1, Interventional, and Treatment
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.
Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Treatments are administered in sequence of A-B-C
Drug: Treatment A · Drug: Treatment B · Drug: Treatment C
Treatments are administered in sequence of A-C-B
Drug: Treatment A · Drug: Treatment B · Drug: Treatment C
Treatments are administered in sequence of C-A-B
Drug: Treatment A · Drug: Treatment B · Drug: Treatment C
Treatments are administered in sequence of C-B-A
Drug: Treatment A · Drug: Treatment B · Drug: Treatment C
Treatments are administered in sequence of B-C-A
Drug: Treatment A · Drug: Treatment B · Drug: Treatment C
Treatments are administered in sequence of B-A-C
Drug: Treatment A · Drug: Treatment B · Drug: Treatment C
Elinzanetant (BAY 3427080), dosage 1
Elinzanetant (BAY 3427080), dosage 2
Elinzanetant (BAY 3427080), dosage 3
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
Plan to share: No — Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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