Ignite Creation Date:
2024-05-06 @ 4:08 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04889287
Status:
COMPLETED
Last Update Posted:
2023-08-09
First Post:
2021-05-14
Brief Title:
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
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Open-label One-sequence Crossover Study to Determine the Effects of Multiple Doses of Elinzanetant on the Pharmacokinetics of Rosuvastatin in Healthy Participants
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 elinzanetantIn 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 25 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
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 elinzanetantIn 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 25 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-004635-25 | EUDRACT_NUMBER | None | None |