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

NCT07229404 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-01-27

No results posted yet for this study

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

Interventions

DRUG

Treatment A

Elinzanetant (BAY 3427080), dosage 1

DRUG

Treatment B

Elinzanetant (BAY 3427080), dosage 2

DRUG

Treatment C

Elinzanetant (BAY 3427080), dosage 3

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-05
Primary Completion
2026-01-14
Completion
2026-01-14

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07229404 on ClinicalTrials.gov