Eligibility Details:
Inclusion Criteria:
- Are overtly healthy males or females, as determined by medical history and physical
examination
- Male participants:
- Men, regardless of their fertility status, with partners who are nonpregnant
women of childbearing potential, must agree to either remain abstinent (if this
is their preferred and usual lifestyle) or use condoms with spermicide as well as
1 additional highly effective (<1% failure rate) method of contraception or
effective method of contraception (such as diaphragms with spermicide) for 3
months following dosing
- Men with pregnant partners should use condoms with spermicide during intercourse
for the duration of the study or for 3 months following dosing, whichever is
longer
- Men who are in exclusively same-sex relationships (as their preferred and usual
lifestyle) or with female partners of nonchildbearing potential are not required
to use contraception
- Men should refrain from sperm donation for the duration of the study or for 3
months following the last dose of study drug, whichever is longer
- Female participants of nonchildbearing potential, including those who are:
- Infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy,
bilateral salpingectomy, confirmed tubal ligation, or tubal occlusion) or
congenital anomaly such as Müllerian agenesis; or
- Postmenopausal, defined as 1 of the following:
- A woman at least 50 years of age with an intact uterus, not on hormone
replacement therapy, who has had either:
- Cessation of menses for at least 1 year; or
- At least 6 months of spontaneous amenorrhea with a follicle-stimulating
hormone level ≥40 milli-international units per milliliter (mIU/mL) at
screening
- A woman at least 55 years of age, not on hormone replacement therapy, who
has had at least 6 months of spontaneous amenorrhea; or
- A woman at least 55 years of age with a diagnosis of menopause prior to
starting hormone replacement therapy
- Have a body mass index (BMI) of 18.0 to 35.0 kilograms per square meter (kg/m²),
inclusive
Exclusion Criteria:
- Have a marked baseline prolongation of/corrected QT (QTc) interval (for example,
repeated demonstration of a QTcB interval >450 milliseconds [msec] for males or >470
msec for females);
- A history of additional risk factors for Torsades de Pointes (for example, heart
failure, hypokalemia, family history of Long QT Syndrome);
- The use of concomitant medications that prolong the QT/QTc interval
- Have an abnormal blood pressure (BP) (taken after the participant has been in a supine
position for at least 5 minutes) for the population, as determined by a systolic BP
>140 millimeters of mercury (mmHg) or a diastolic BP >90 mmHg at screening or a
preexisting history of hypertension. Up to 2 additional measurements may be taken
after an appropriate resting interval at screening to confirm eligibility
- Have a significant history of or current cardiovascular, respiratory, hepatic, renal,
gastrointestinal, endocrine (such as Cushing syndrome, hyperthyroidism,
hyperaldosteronism), hematological, or neurological disorders capable of significantly
altering the absorption, metabolism, or elimination of drugs; of constituting a risk
when taking the investigational medicinal product (IMP); or of interfering with the
interpretation of data
- Have a history of or current significant psychiatric disorders
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
