| Eligibility |
Inclusion Criteria:
- Subject is a healthy female subject.
- Subject has a body mass index (BMI) range of 18.5 to 34.0 kg/m^2, inclusive and weighs
at least 50 kg at screening.
- Postmenopausal female subjects only: Subject is postmenopausal according to 1 of the
following criteria:
- Spontaneous amenorrhea for = 12 consecutive months
- Spontaneous amenorrhea for = 6 months with biochemical criteria of menopause
(follicle-stimulating hormone [FSH] > 40 IU/L); or
- Having had bilateral oophorectomy = 6 weeks prior to the screening visit (with or
without hysterectomy)
- Subject agrees not to participate in another interventional study while participating
in the present study.
- Premenopausal female subjects only: Subject has had a regular menstrual cycle (from 25
to 31 days ± 3 days) for 3 months prior to starting the IP administration.
- Premenopausal female subjects only: Subject is not pregnant and at least meets 1 of
the following criteria:
- If the subject is not of childbearing potential: Subject has lost fertility
permanently by surgery excluding oophorectomy (e.g., hysterectomy, bilateral
salpingectomy).
- If the subject is a woman of childbearing potential (WOCBP): Subject agrees to
follow the contraceptive guidance from the time of providing informed consent
through at least 30 days after the final IP administration. However, if the
subject's partner has lost fertility by surgery (vasectomy or bilateral
orchiectomy) etc., confirmed with documentation of both the procedure and absence
of sperm, it is not necessary to implement contraceptive methods.
Note: If absence of sperm cannot be confirmed in the subject's partner who received a
vasectomy, an alternative contraceptive method must be used.
- Premenopausal female subjects only: Subject agrees not to breastfeed or donate ova
from the time of providing informed consent until 30 days after the last IP
administration.
Exclusion Criteria:
- Subject has received any investigational therapy within 28 days or 5 half-lives,
whichever is longer, prior to screening.
- Subject has any condition which makes the subject unsuitable for study participation.
- Subject has a known or suspected hypersensitivity to fezolinetant or any components of
the formulations used.
- Subject has had previous exposure with fezolinetant.
- Subject has any of the liver function tests (alkaline phosphatase [ALP], alanine
aminotransferase [ALT], aspartate aminotransferase [AST] and total bilirubin [TBL]) >
1.5 × upper limit of normal (ULN) on day -1. In such a case, the assessment may be
repeated once.
- Subject has any clinically significant history of allergic conditions (including drug
allergies, asthma, eczema or anaphylactic reactions, but excluding untreated,
asymptomatic, seasonal allergies) prior to first investigational product (IP)
administration.
- Subject has any history or evidence of any clinically significant cardiovascular,
gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic,
urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major
disease or malignancy.
- Subject has/had febrile illness or symptomatic, viral, bacterial (including upper
respiratory infection) or fungal (noncutaneous) infection within 1 week prior to day
-1.
- Subject has any clinically significant abnormality following the physical examination,
electrocardiogram (ECG) and protocol-defined clinical laboratory tests at screening or
on day -1.
- Subject has a mean pulse < 45 or > 90 bpm or hypertension as defined by a systolic
blood pressure = 130 mmHg or diastolic blood pressure = 80 mmHg based on the average
of 3 readings on at least 2 different occasions during the screening period.
- Subject has a mean corrected QT interval using Fridericia's formula (QTcF) of > 470
msec on day -1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG
may be taken.
- Subject has used any prescribed or nonprescribed drugs (including vitamins,
contraception [oral, injectable, implantable or transdermal] and natural and herbal
remedies, e.g., St. John's Wort) in the 2 weeks prior to first IP administration and
for hormone replacement therapy (HRT) in the 8 weeks prior to first IP administration,
except for occasional use of acetaminophen (up to 2 g/day) and topical dermatological
products, including corticosteroid products.
- Subject has smoked, used tobacco-containing products and nicotine or
nicotine-containing products (e.g., electronic vapes) within 6 months prior to
screening.
- Subject has a history of consuming > 7 units of alcoholic beverages per week within 6
months prior to screening or has a history of alcoholism or drug/chemical/substance
abuse within 2 years prior to screening (note: 1 unit = 12 ounces of beer, 4 ounces of
wine, 1 ounce of spirits/hard liquor) or the subject tests positive for alcohol at
screening or on day -1.
- Subject has used any drugs of abuse (amphetamines, barbiturates, benzodiazepines,
cannabinoids, cocaine and/or opiates) within 3 months prior to day -1 or the subject
tests positive for drugs of abuse (amphetamines, barbiturates, benzodiazepines,
cannabinoids, cocaine and opiates) at screening or on day -1.
- Subject has used any inducer of cytochrome P450 (CYP) 1A2 in the 3 months prior or
inhibitors of CYP 1A2 in the 2 weeks or 5 half-lives of the inhibitor, whichever is
longer, prior to day -1.
- Subject has had significant blood loss, donated = 1 unit (450 mL) of whole blood or
donated plasma within 7 days prior to day -1 and/or received a transfusion of any
blood or blood products within 60 days.
- Subject has a positive serology test for hepatitis A virus antibodies (immunoglobulin
M), hepatitis B core antibodies, hepatitis B surface antigen, hepatitis C virus
antibodies or antibodies to human immunodeficiency virus type 1 and/or type 2 at
screening.
- Subject is an employee of Astellas, the study-related contract research organizations
(CROs) or the clinical unit.
- Premenopausal female subjects only: Subject has been pregnant within 6 months or has
been breastfeeding within 3 months prior to the screening visit.
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