- Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years inclusive at
- WONCBP may be included if they are either surgically sterile (hysterectomy and/or
oophorectomy) or postmenopausal for ≥1 year (with follicle stimulating hormone [FSH]
level ≥38 mIU/mL) and must have a negative pregnancy test result within 24 hours
before administration of the study drug or placebo.
- Women who are surgically sterile must provide documentation of the procedure by an
operative report or by an ultrasound scan report.
- Sexually active men must agree to use a medically acceptable form of contraception
during the study and continue using it for 12 weeks after study drug or placebo
- Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight ≥50 kg.
- Healthy as determined by the investigator on the basis of medical history, physical
examination, clinical laboratory test results, vital sign measurements, and 12-lead
- Serum creatinine level must be less than 1.30 mg/dL. (Normal range: 0.44 to 1.24
- Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must
be able to abstain from smoking during the inpatient stay.
- Presence or history of any disorder that may prevent the successful completion of the
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal,
endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
- Any surgical or medical condition that may interfere with the absorption,
distribution, metabolism, or excretion of the study drug or placebo.
- Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before
administration of study drug or placebo.
- Any history of clinically important cardiac arrhythmias.
- Familial history of long QT syndrome or unexpected cardiac death.
- History of drug abuse within 1 year before before administration of study drug or