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

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