A study to learn how safe elinzanetant is, how it affects the body, and how it moves into, through and out of the body after single and multiple doses in Japanese healthy female adults
- Conditions
- Vasomotor Symptoms as a sex-hormone dependent disorder in women and men
- Registration Number
- JPRN-jRCT2071210049
- Lead Sponsor
- Myoishi Masashi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 62
Japanese participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, blood pressure, pulse rate, 12 lead electrocardiogram (ECG), body temperature, and laboratory tests.
- Non-smoker, at least from 3 months before the screening visit onwards.
- Body weight of at least 40 kg and body mass index (BMI)
within the range 18.0 and 30.0 kg/m^2 (inclusive).
- Pregnant or breastfeeding women.
- Any clinically relevant abnormal findings in medical history and physical examination.
- 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.
- Relevant diseases or febrile illness within the last 4 weeks prior to the first study intervention administration.
- Regular use of medicines, or dietary supplements or other substances, e.g., carnitine products, anabolics, high dose vitamins.
- Use of any systemic or topical medicine or substance within 4 weeks before first study drug intervention, which oppose the study objectives, or which might influence them. This includes medicines and natural remedies (e.g St. Johns wort) that are altering the activity of CYP3A4 enzyme and the transporters Breast Cancer Resistance Protein (BCRP) and P-gp.
- ECG PR interval 210 msec, QT interval corrected using Bazetts formula (QTCB) 450 msec, QRS duration 110 msec at screening visit.
- ECG: PR interval > 210 msec, QT interval corrected using Bazetts formula (QTcB) >450 msec, QRS duration > 110 msec at screening visit.
- Systolic blood pressure below 90 or above 140 mmHg;
diastolic blood pressure below 40 or above 90 mmHg at
screening visit.
- Pulse rate below 50 or above 90 beats per minute (bpm; a lower pulse rate between 45 and 50 bpm is acceptable in case of normal thyroid function and absence of symptoms of bradycardia) at screening visit.
- Participants with a presence of any of the following, confirmed by a repeat test: aspartate aminotransferase (AST), alanine aminotransferase (ALT) and/or bilirubin above 1.2 x upper limit of normal (ULN) at screening visit.
- Participants with a presence of gamma-glutamyl transferase (GGT) > ULN confirmed by a repeat test, CK (creatine kinase) >2x ULN, and thyroid-stimulating hormone (TSH) outside normal range at screening visit.
- History of COVID-19 (coronavirus disease 2019).
- Suspected or confirmed active or prior SARS-CoV-2 (severe acute respiratory syndrome coronavirus type 2) infection according to local guidelines/practice.
- Contact with SARS-CoV-2- positive or COVID-19 patient within the last 4 weeks prior to admission to the study site.
- Positive SARS-CoV-2 viral RNA (ribonucleic acid) test.
- Vaccination against SARS-CoV-2 within 14 days before first administration of the study intervention or vaccination planned before completion of the last study visit.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method