Status:
COMPLETED
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
Lead Sponsor:
Bayer
Conditions:
Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men
Eligibility:
MALE
18-65 years
Phase:
PHASE1
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. ...
Eligibility Criteria
Inclusion
- Participant must be 18 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, laboratory tests, and ECG, vital signs, respiratory rate and body temperature.Weight.
- Body weight above or equal 50 kg and body mass index (BMI) within the range 18.0 and 30.0 kg/m\*2 (inclusive).
- Male.
- Contraceptive use by men or female partners of male participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies:
- \-- a. Male participants:
- Male participants of reproductive potential must agree to use a condom (with or without spermicide) when sexually active. This applies for the time period between the signing of the informed consent form until 7 days after the last dose of study intervention.
- Female partners of childbearing potential of male participants do not need to follow special precautions.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
Exclusion
- 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.
- Use of any systemic or topical medicines or substances which oppose the study objectives, or which might influence them (for further information, see Section 6.8) within 4 weeks prior to screening.
- Participants with positive serology for any of hepatitis B, hepatitis C, of HIV.
- Clinically relevant deviations of the screened safety laboratory parameters in clinical chemistry, hematology, or urinalysis from reference ranges.
- Clinically relevant findings in the ECG such as a second- or third-degree atrioventricular (AV) block, prolongation of the QRS complex over 120 msec or QT interval frequency-corrected according to Bazett's formula (QTcB) -prolongation over 450 msec at screening.
- Participants with a presence of any of the following, confirmed by a repeat test: AST, alanine aminotransferase (ALT) and/or bilirubin above 1.2 x upper limit of normal (ULN) (at screening or Day -1).
- Known intolerance to statins.
- Current or medical history of myopathy, rhabdomyolysis or myasthenia.
Key Trial Info
Start Date :
May 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04889287
Start Date
May 26 2021
End Date
September 29 2021
Last Update
August 9 2023
Active Locations (1)
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1
CRS Clinical-Research-Services Mannheim GmbH
Mannheim, Baden-Wurttemberg, Germany, 68167