Comparison of the Extent to Which the Drug Given as Two Different Capsule Sizes Becomes Available to the Body

Single Center, Randomized, Open-label, Cross-over Study to Investigate the Pharmacokinetics of Two Oral Formulations of Elinzanetant After Single Dosing in Healthy Participants

Researchers are looking for a new way to treat women who have symptoms by hormonal changes, like those that happen in women during menopause. These symptoms can include hot flashes, night sweats, and changes in blood pressure. These symptoms are caused by hormonal changes occurring during menopausal transition when women may have also changes in their monthly cycles. The menopausal transition most often begins between ages 45 and 55 and leads to menopause, a point in time 12 months after a woman's last period.

The study drug, elinzanetant, was designed to treat symptoms caused by hormonal changes. Before a new treatment can be approved for people to take, researchers perform clinical trials to better understand how this treatment works and to investigate safety.

The purpose of this study is to assess the blood levels of elinzanetant when given as 2 capsules of dose A (what is intended for further research and future commercialization) and also to compare the blood levels when given as 3 capsules of dose B (what was used for research up to now). Furthermore, researchers want to find out if taking of elinzanetant on two time points leads to differences in blood levels of elinzanetant.

This trial will be performed in healthy women aged 40 to 65 years.

Study Overview

• Status: Completed
• Conditions: Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men
• Intervention / Treatment: Drug: Elinzanetant (BAY3427080) treatment A; Drug: Elinzanetant (BAY3427080) treatment B

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Mannheim, Baden-Württemberg, Germany, 68167
      • CRS Clinical-Research-Services Mannheim GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participant must be 40 to 65 years of age inclusive, at the time of signing the informed consent.
• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, blood pressure, pulse rate, 12-lead electrocardiogram, body temperature, and laboratory tests.
• Non-smoker, at least from 3 months before the screening visit onwards
• Body weight of at least 50 kg and BMI within the range 18.0 and 30.0 kg/m*2 (inclusive) at screening.

• Female

  • Women of childbearing potential will have to use highly effective non-hormonal contraception when having sexual intercourse with a male partner from signing the informed consent form until 5 days after last dose of the study drug. Acceptable methods of contraception for this study are listed in protocol.

  • Women of non-childbearing potential are not required to use contraception. Non-childbearing potential is defined as

    • Postmenopausal state confirmed by follicle stimulating hormone (FSH) level >40 U/L, or above reference range from the local laboratory, or
    • Surgically sterilized by bilateral tubal ligation, or bilateral oophorectomy with or without hysterectomy documented by medical report verification

Exclusion Criteria:

• Pregnant or breastfeeding women.
• Any clinically relevant abnormal findings in medical history and physical examination which in the opinion of the investigators, may put the participant at risk because of her participation in the trial or provide difficulties in interpreting the trial data.
• History or evidence of any clinically relevant cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other clinically relevant disease, as judged by the investigator.
• Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention will not be normal.
• Any medical disorder, condition or history of such that would impair the participant's ability to participate or complete this study in the opinion of the investigator.
• Known hypersensitivity to the study interventions (active substances, or excipients of the preparations).
• Known severe allergies e.g., allergies to more than 3 allergens, allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with corticosteroids, urticaria or significant non-allergic drug reactions.
• Relevant diseases within the last 4 weeks prior to the first study intervention administration.
• Febrile illness within 4 weeks before first study intervention administration.
• Regular use of medicines.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants receive study medication on time point 1; Participants will receive two single doses of elinzanetant in two different treatments in a randomized sequence (Treatment A, Treatment B).	Drug: Elinzanetant (BAY3427080) treatment A; Single oral dose; Drug: Elinzanetant (BAY3427080) treatment B; Single oral dose
Experimental: Participants receive study medication on time point 2; Participants will receive two single doses of elinzanetant in two different treatments in a randomized sequence (Treatment A, Treatment B).	Drug: Elinzanetant (BAY3427080) treatment A; Single oral dose; Drug: Elinzanetant (BAY3427080) treatment B; Single oral dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC of elinzanetant	AUC: Area under the concentration vs. time curve from zero to infinity after single (first) dose	Period 1: Day 1-9, Day 11, Day 13, Day 15; Period 2: Day 1-7, Day 8 (follow up visit)
Cmax of elinzanetant	Cmax: Maximum observed drug concentration in measured matrix after single dose administration	Period 1: Day 1-9, Day 11, Day 13, Day 15; Period 2: Day 1-7, Day 8 (follow up visit)

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of treatment-emergent adverse events (TEAEs)	Approximately 2 to 3 months
Severity of treatment-emergent adverse events (TEAEs)	Approximately 2 to 3 months

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2021
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: April 7, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 21665 (Other Identifier: City of Hope Medical Center); 2020-005715-49 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No