A Single Dose Evaluation of the Effects of Renal Impairment on Deflazacort Pharmacokinetics

Inclusion Criteria: * Continuous non-smokers or moderate smokers * For a female of non-childbearing potential: must have undergone a sterilization procedures or be postmenopausal with amenorrhea for at least 1 year prior to the first dose and FSH serum levels consistent with postmenopausal status * A non vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days * If male, must agree not to donate sperm from dosing until 90 days Subject with ESRD on Hemodialysis * Adult male or female, 18 80 years of age * BMI ≥ 18.5 and ≤ 40.0 kg/m2 - Subject is maintained on a stable regimen of HD at least 3 months Healthy Subject * Healthy adult male and female subjects will be matched 1:1 to a specific subject in the ESRD cohort based upon age, BMI, and gender \[1:1\]. The following criteria should be fulfilled: * 18 to 80 years of age. Age must be within ± 15 years of the matched subject's age in the ESRD cohort * BMI ≥ 18.5 and ≤ 40.0 kg/m2. BMI must be within ± 15% of the matched subject's BMI in the ESRD cohort * Has a CLcr ≥ 90 mL/min Exclusion Criteria: * Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study * History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds (e.g., steroids or their formulations including lactose and corn starh) * History (within the last year prior to dosing) or presence of peptic ulcers * History or presence of: * Gastritis or esophagitis, diverticulitis, ulcerative colitis (if there is probability of impending perforation), abscess or pyogenic infections, or fresh intestinal anastomosis * Previous corticoids-induced myopathy * Ocular herpes simplex * Symptomatic cardiomyopathy at screening * Immunosuppression or other contraindications for corticosteroid treatment * History of chronic systemic fungal or viral infections * Galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption * Osteoporosis * Myasthenia gravis * Epilepsy * Idiopathic hypocalcuria * Seated blood pressure is less than 90/40 mmHg or greater than 170/100 mmHg * Seated heart rate is lower than 40 bpm or higher than 99 bpm * QTcF interval is \> 500 msec * Has received any live or live-attenuated vaccine within 30 days * Has received any immunosuppressive agents, coal tar, and/or radiation therapies within 30 days * Has received injectable corticoids in the 12 weeks prior to dosing or any oral form of corticoids in 30 days * Unable to refrain from or anticipates the use of: * Any drug known to be moderate or strong inhibitors or inducers of cytochrome P450 (CYP) 3A or P-glycoprotein (P-gp) for 14 days or 28 days, respectively * Any medication or substance which cannot be discontinued at least 14 days * Female subjects of childbearing potential * Female subjects who are pregnant or lactating * Positive results at screening for HIV, HBsAg or HCV * Has been on a diet incompatible with the on study diet within 28 days * Donation of blood or significant blood loss within 56 days * Plasma donation within 7 days * Participation in another clinical trial within 28 days Subject with ESRD * Is a regular user of any medication that would significantly alter glomerular filtration rate, e.g., cimetidine * Has presence of a renal carcinoma or acute renal disease caused by infection or drug toxicity * History of drug abuse within the past 2 years * Has a positive urine/breath alcohol or urine/serum/saliva drug testing Normal Renal Function * History or presence of alcoholism or drug abuse within the past 2 years * Positive urine drug or urine/breath alcohol results