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A Study to Learn How Much Rosuvastatin Gets Into the Blood When Taken With or Without Elinzanetant and to Learn About the Safety of Elinzanetant in Healthy Participants

NCT04889287 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-08-09

No results posted yet for this study

Summary

Researchers are looking for a better way to treat people who have symptoms caused by hormonal changes, like those that happen in women during menopause. These symptoms can include vasomotor symptoms. Before a treatment can be approved for patients to take, researchers do clinical studies to better understand its safety and what happens to the treatment in the body.

The study drug, elinzanetant, was designed to treat vasomotor symptoms. Rosuvastatin is already approved for doctors to prescribe and is used to treat high cholesterol levels and prevent heart problems. It is important for researchers to know if taking elinzanetant will affect how other drugs work in the body. Researchers regularly use rosuvastatin in studies to learn how it affects drugs like elinzanetant.In this study, the researchers will study how much elinzanetant gets into the participants' blood when taken with or without rosuvastatin. The study will include about 16 male participants who are between 18 and 65 years old. The participants will all take 5 milligrams (mg) of rosuvastatin and 120 mg of elinzanetant as capsules by mouth. On some days, they will take only rosuvastatin or only elinzanetant. On other days, they will take both study treatments. Each participant will be in the study for up to 6 weeks. But, the entire study will last about 2.5 months.

During the study, all of the participants will stay at the study site for 17 days. Blood and urine samples will be collected. The physician will also check the participants' heart health using an electrocardiogram (ECG). The participants will answer questions about how their well being and taken medications.

Conditions

  • Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men

Interventions

DRUG

Elinzanetant (BAY3427080)

Once daily over 12 days

DRUG

Rosuvastatin

Single doses on Day 1, Day 8, and Day 13

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2021-05-26
Primary Completion
2021-07-23
Completion
2021-09-29

Countries

  • Germany

Study Locations

More Related Trials

Entities

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 NCT04889287 on ClinicalTrials.gov