ABOUT THIS STUDY
- Male and/or female subjects between the ages of 18 and 75 years, inclusive
- For severe renal impairment group, subjects with creatinine clearance of less than 30 mL/min, but not yet on dialysis and in good general health commensurate with the population with chronic renal disease; however, subjects with type 1 and 2 diabetes that are reasonably controlled and who do not have a predisposition to severe hypoglycemia can both be included.
- For normal renal function group, healthy subjects with creatinine clearance of greater than 80mL/min and demographically comparable to subjects with impaired renal function
- Pregnant or nursing women; women of childbearing potential (WOCBP) who are unwilling
or unable to use an acceptable method of contraception as outlined in the protocol
from at least 14 days prior to the first dose of study medication.
- For normal renal function group, use of prescription or non-prescription drugs,
vitamins, or dietary supplements within 7 days of 5 half-lives (whichever is longer)
prior to the first dose of study medication.
Herbal supplements and hormone replacement therapy must be discontinued 28 days prior to
the first dose of study medication. Acetaminophen at doses of ≤ 2 grams/day is permitted.
- For renal impairment group, a known history of clinically significant coronary heart
disease, cerebrovascular disease or peripheral vascular disease and/or an
event/intervention during the past 6 months. Systemic therapy with CYP3A or CYP2D6
inhibitors within 7 days or 5 halflives (whichever is longer) prior to the first dose
of trial medication.
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