A Study to Learn How Safe the Study Treatment Elinzanetant is and How it Moves Into, Through and Out of the Body When Given as Single Increasing Doses That Are Higher Than Normally Used Compared to Placebo and Moxifloxacin in Healthy Participants

This is an interventional basic science trial for Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men Read More

Inclusion Criteria:

• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, blood pressure, pulse rate, respiratory rate, body temperature and electrocardiogram (ECG).
• Body weight of at least 50 kg.
• Body mass index (BMI) within the range 18.0 to 30.0 kg/m^2 (inclusive).
• Male subjects of reproductive potential must agree to use a condom (with or without spermicide) when sexually active with a female partner and refrain from donating sperm. This applies for the time period between the signing of the informed consent form (ICF) until 5 days after the last administration of study intervention. Female partners of childbearing potential of male subjects do not need to follow special precautions.
• Women of childbearing potential will have to use a highly effective non-hormonal contraception when having sexual intercourse with a male partner from signing of the ICF until 5 days after the last administration of study intervention.

Exclusion Criteria:

• Any clinically relevant abnormal findings in medical history and physical examination. Including: 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; Diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention will not be normal.
• Known or suspected hypersensitivity or allergy to the study interventions or other fluoroquinolone products.
• Relevant diseases within the last 4 weeks prior to the first administration of study intervention, including febrile illness.
• Contraindications for the use of moxifloxacin, including: Medical history of seizures or psychiatric disorders, myasthenia gravis, severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN; also known as Lyell's syndrome), Stevens Johnson syndrome (SJS) and Acute Generalized Exanthematous Pustulosis (AGEP), glucose-6-phosphate dehydrogenase deficiency.
• Pregnant or breastfeeding women.
• Tendency for vasovagal reactions or history of syncope.
• Use of mild, moderate, or strong CYP3A4 and P-gp inhibitors from 2 weeks, and use of CYP3A4 and P-gp inducers from 4 weeks prior to the first administration of study intervention.
• Use of drugs which may affect absorption and systemic administration of any broad-spectrum antibiotic within 1 week prior to first administration of study intervention.
• Use of drugs which may affect absorption by increasing the gastrointestinal pH e.g. proton pump inhibitors from 2 weeks prior to first administration of study intervention.
• Use of any herbal products or St. John's wort within 4 weeks prior to the first administration of study intervention.