A Single Dose Evaluation of the Effects of Moderate Hepatic Impairment on Deflazacort Pharmacokinetics

Inclusion Criteria: All Subjects * Continuous non-smokers or moderate smokers. * For a female of non-childbearing potential: must have undergone one a sterilization procedures or be postmenopausal with amenorrhea for at least 1 year prior to dosing 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 Moderate Hepatic Impairment * Adult male or female, 18 80 years of age * BMI ≥ 18.5 and ≤ 40.0 kg/m2 * Subject's score on the Child-Pugh scale must range from 7 to 9 (moderate hepatic insufficiency) * Subject has a diagnosis of chronic (\> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency with features of cirrhosis due to any etiology. Healthy Subject \- Healthy adult male and female subjects will be matched 1:1 to a specific subject in the moderate hepatic impairment cohort based upon age, BMI, and gender. 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 drug, related compounds (e.g., steroids or their formulations including lactose and corn starch). * 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 160/95 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, vitamin supplements, natural or herbal supplements 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. * 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 Moderate Hepatic Impairment * Has history of organ transplant. * History of drug abuse within the past 2 years * Has a positive urine drug or urine/breath alcohol testing Healthy Subject * History or presence of alcoholism or drug abuse within the past 2 years * Positive urine drug or urine/breath alcohol testing results at screening or check in. * Positive results at screening for HBsAg or HCV.