- Males and females, aged 18 to 65.
- Adequate hepatic function.
- Documented creatinine clearance by Cockroft-Gault formula indicative of the
respective level of renal impairment: Severe renal impairment (CrCl mL/min/1.73m2), moderate renal impairment (30 ≤ CrCl ≤50 mL/min/1.73m2), mild renal
impairment (50 80
- Use of any investigational drug or biologic within 4 weeks prior to the screening
visit of during the screening period.
- Ongoing treatment with Digoxin or strong CYP3A4 inhibitors or inducers.
- Uncontrolled hypertension (for renally impaired subjects only).