Status:
COMPLETED
A Study to Learn More About How the Study Treatment Elinzanetant (or BAY3427080) Moves Into, Through and Out of the Body, How Safe it is and How it Affects the Body After Taking Single and Multiple Doses in Healthy Women Aged 40 to 65 Years
Lead Sponsor:
Bayer
Conditions:
Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men
Hot Flashes
Eligibility:
FEMALE
40-65 years
Phase:
PHASE1
Brief Summary
Researchers are looking for a better way to treat men and women with vasomotor symptoms, a condition of having hot flashes caused by hormonal changes. In women, these hormonal changes happen in the t...
Eligibility Criteria
Inclusion
- 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, vital signs, laboratory tests and electrocardiogram (ECG).
- Race: Chinese in China mainland.
- Body weight of at least 40 kg and body mass index (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 intervention.
- Women of non-childbearing potential are not required to use contraception.
- Capable of giving signed informed consent.
Exclusion
- Any clinically relevant abnormal findings in medical history and physical examination at screening or Day -1 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.
- Known hypersensitivity to the study interventions (active substances, or excipients of the preparations).
- Use of any systemic or topical medicine or substance which oppose the study objectives, or which might influence them within 4 weeks before first administration of study intervention. This includes but is not limited to CYP P450 inducers/inhibitors, OATP substrates or P-gp substrates with narrow therapeutic range (e.g. digoxin, dabigatran etc).
- Regular use of therapeutic drugs or supplements, e.g., carnitine products, anabolics, high dose vitamins.
- Use of herbal drugs or natural remedies, e.g. St. John's wort within 4 weeks before first study intervention administration.
Key Trial Info
Start Date :
May 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2022
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05381142
Start Date
May 23 2022
End Date
July 11 2022
Last Update
July 27 2022
Active Locations (1)
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1
The First Affiliated Hospital of Guangzhou University of TCM
Guangzhou, Guangdong, China, 510405