- Breath alcohol test at Screening and Day -1 must be negative.
- Body mass index (BMI) of ≥ 17.5 to ≤ 40.0 kg/m2; and a total body weight >50 kg (110
Additional inclusion criteria for subjects with renal impairment:
- Meet the following eGFR criteria during the screening period based on the MDRD
- Severe renal impairment: eGFR
- Moderate renal impairment (Part 2 only): eGFR ≥30 mL/min and
- Any form of renal impairment except acute nephritic syndrome (subjects with history of
previous nephritic syndrome but in remission can be included).
- Stable concomitant drug regimen.
- Renal transplant recipients.
- Urinary incontinence without catheterization.
- Subjects with clinically significant infections within the past 3 months (for example,
those requiring hospitalization, or as judged by the Investigator), evidence of any
infection (including influenza) within the past 7 days prior to baseline, history of
disseminated herpes simplex infection or recurrent or disseminated herpes zoster.
- Subjects with a malignancy or with a history of malignancy, with the exception of
adequately treated or excised non-metastatic basal cell or squamous cell cancer of the
skin or cervical carcinoma in situ.
- History of or current positive results for human immunodeficiency virus, Hepatitis B,
Additional exclusion criteria for subjects with renal impairment:
- Subjects requiring hemodialysis and peritoneal dialysis.
- Screening BP ? 180 mm Hg (systolic) or ? 110 mm Hg (diastolic).
- Screening supine 12-lead ECG demonstrating QTcF >470 msec or a QRS interval >120 msec.