CRS Clinical-Research-Services Mannheim GmbH
Mannheim, Baden-Wurttemberg, 68167, Germany
NCT Number: NCT04889287
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.
Looking for future studies?
Notify Me18 year–65 year
Male
Interventional
Phase 1
Mannheim, Baden-Wurttemberg, 68167, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-- a. Male participants:
Exclusion criteria
Once daily over 12 days
Single doses on Day 1, Day 8, and Day 13
Time frame: Day 1-3, Day 8-16
Time frame: Day 1-3, Day 8-16
Time frame: Approximately 2.5 months
Time frame: Approximately 2.5 months
Bayer
Industry
Open-label, One-sequence Crossover Study to Determine the Effects of Multiple Doses of Elinzanetant on the Pharmacokinetics of Rosuvastatin in Healthy Participants
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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