Food Effect and Bioavailability of Deflazacort Formulations in Healthy Volunteers

Inclusion Criteria:

- Healthy males and females ≥ 18 and ≤ 55 at the time of screening.

- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2, inclusive, at screening and Day -1.

- Women of nonchildbearing potential, defined as tubal ligation, hysterectomy,
postmenopausal (amenorrhea for > 1 year; confirmed by FSH), or oophorectomy.

- Males who are sexually active and whose partners are females of childbearing
potential must agree to use condoms from screening through 90 days after the last
dose of study drug.

- Males must agree to not donate sperm from screening through 90 days after the last
dose of study drug.

- Subjects must be healthy and without clinically significant abnormalities as assessed
by review of medical and surgical history, physical examination, vital signs
measurement, electrocardiogram (ECG), and laboratory evaluations conducted at the
screening visit and on CPU admission.

- Subjects must be nonsmokers, defined as having abstained from tobacco- or
nicotine-containing products (eg, cigarettes, chewing tobacco, snuff, nicotine
patches, and electronic cigarettes) in the 3 months prior to screening.

Exclusion Criteria:

- Positive pregnancy test or lactating.

- History or presence of conditions which, in the judgment of the investigator, are
known to interfere with the absorption, distribution, metabolism, or excretion of
drugs.

- History or presence of conditions that may place the subject at increased risk as
determined by the investigator.

- History of presence of hypersensitivity of idiosyncratic reaction to the study drugs
or related compounds (eg, steroids or their formulations including lactose).

- History of surgery or major trauma within 12 weeks of screening, or surgery planned
during the study.

- History of alcohol abuse, illicit drug use, significant mental illness, physical
dependence to any opioid, or any history of drug abuse or addiction within 12 months
of screening.

- Use of prescription medications within 14 days or any drugs that inhibit study drug
specific cytochrome P450(s) within 14 days or any drugs that induce specific
cytochrome P450s, including St. John's Wort, within 28 days, or 5 half-lives,
whichever is longer, of administration of the first dose of study drug and throughout
the study.

- Use of over the-counter (OTC) drugs (including herbal preparations) within 7 days or
5 half-lives, whichever is longer, prior to administration of the first dose of study
drug and throughout the study.

- Has taken other investigational drugs, including deflazacort or related compounds, or
participated in any clinical study within 30 days or 5 half-lives of the
investigational drug's PK, pharmacodynamic, or biological activity, whichever is
longer, prior to first dose of study drug in this study.

- Has received any immunosuppressive agents, coal tar, and/or radiation therapies
within 30 days prior to the first dose of study drug.

- Has received injectable corticoids in the 12 weeks prior to the first dose of study
drug or any oral form of corticoids in the 30 days prior to the first dose of study
drug.

- Has received any live or live-attenuated vaccine within 30 days prior to the first
dose of study drug and/or intends to receive one on study.

- Significant blood loss (> 450 mL) or has donated 1 or more units of blood or plasma
within 6 weeks prior to study participation.

- Positive urine drugs of abuse, alcohol breath test, or urine cotinine screen.

- Positive screen for human immunodeficiency virus (HIV)-1 and HIV-2 antibodies,
hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody.

- Estimated creatinine clearance < 80 mL/min using Cockcroft-Gault equation.

- QTcF interval > 450 msec at screening.

- Unwilling or unable to consume standardized meals.

- Unwilling or unlikely to comply with the requirements of the study.