About Clinical Research
Study #51123

 Women of non-childbearing potential defined as either permanently sterilized at least 4 months post-surgical sterilization
which may include:
• Bilateral salpingectomy
• Tubal ligation or tubal occlusion
• Hysterectomy, or oophorectomy with or without hysterectomy
• Postmenopausal (defined as amenorrhea for at least 12 consecutive months)
 Women of childbearing potential (WOCBP) and willing to practice one of the following highly effective methods of birth
control:
• Vasectomized partner
• Hormonal or non-hormonal intrauterine device; OR
• Willing to use two of the following methods:
o Hormonal birth control
o Vaginal diaphragm with spermicide
o Condom with spermicide, or sponge with spermicide; OR
o Remain abstinent from screening through 30 days after the last dose of study drug.
 Women of childbearing potential or women of non-childbearing potential with a negative serum pregnancy test at screening
and a negative urine pregnancy test at admission.
 Male subject who is permanently sterile (defined as bilateral orchidectomy or vasectomy, provided the absence of sperm has
been medically confirmed) or if fertile (defined as post-puberty and not permanently sterile) must be willing to use a condom
or remain abstinent, AND abstain from donating sperm to the end of study visit.