An open-label, non-randomized, fixed-sequence crossover study to investigate the effects of the proton pump inhibitor esomeprazole on the pharmacokinetics of elinzanetant (BAY 3427080) as well as assessment of the absolute bioavailability of elinzanetant using a single intravenous microtracer dose of [13C5]BAY 3427080 in male and female healthy participants.
- Conditions
- hot flashesPostmenopausal symptoms10074469
- Registration Number
- NL-OMON50454
- Lead Sponsor
- Bayer AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 14
1. Participant must be 18 to 65 years of age inclusive, at the time of signing
the informed consent.
2. Participants who are overtly healthy as determined by medical evaluation
including medical history, physical examination, laboratory tests, and cardiac
monitoring.
3. Body weight of at least 50 kg and body mass index (BMI) within the range of
18.0 to 30.0 kg/m^2 (inclusive).
4. Male and female
Contraceptive use by men or women should be consistent with local regulations
regarding the methods of contraception for those participating in clinical
studies.
- 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 (ICF) until 5 days after the last dose of study
intervention. Female partners of childbearing potential of male participants do
not need to follow special precautions.
- Female participants: Women of childbearing potential will have to use highly
effective non-hormonal contraception when having sexual intercourse with a male
partner from signing the ICF until 5 days after last dose of the study drug.
-- Women of non-childbearing potential are not required to use contraception.
Non-childbearing potential is defined as
- Postmenopausal state confirmed by follicle stimulating hormone (FSH) level
>33.4 U/L, or above reference range from the local laboratory, or
- Surgically sterilized by bilateral tubal ligation, bilateral oophorectomy
with or without hysterectomy, or hysterectomy documented by medical report
verification.
1. Any clinically relevant abnormal findings in medical history and physical
examination which in the opinion of the investigators, may put the participant
at risk because of his/her participation in the trial or provide difficulties
in interpreting the trial data.
2. 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.
3. 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.
4. Any medical disorder, condition or history of such that would impair the
participant's ability to participate or complete this study in the opinion of
the investigator.
5. Known hypersensitivity to the study interventions (active substances, or
excipients of the preparations).
6. Known severe allergies e.g., allergies to more than 3 allergens, allergies
affecting the lower respiratory tract - allergic asthma, allergies requiring
therapy with corticosteroids, urticaria or significant nonallergic drug
reactions.
7. Relevant diseases within the last 4 weeks prior to the first study
intervention administration.
8. Febrile illness within 4 weeks before first study intervention
administration.
9. Contraindications for the use of esomeprazole, especially known hereditary
problems of fructose intolerance, glucose-galactose malabsorption or
sucrase-isomaltase insufficiency
10. Use of drugs which may affect absorption (e.g. loperamide, metoclopramide)
within 1 week before first study drug administration.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To investigate the effect of multiple doses of esomeprazole on the PK of<br /><br>elinzanetant</p><br>
- Secondary Outcome Measures
Name Time Method <p>To investigate the safety and tolerability of elinzanetant<br /><br><br /><br>To determine the absolute bioavailability of elinzanetant after single oral<br /><br>administration of elinzanetant together with an IV microtracer dose of<br /><br>[13C5]BAY3427080</p><br>