Comparison of Nikkomycin Z Bioavailability Under Fed and Fasting Conditions

To compare the single-dose bioavailability of Nikkomycin Z 500 mg (two 250 mg capsules)
under fed and fasting conditions.

Inclusion Criteria:

- Be at least 18 years of age and not over 40 years of age

- Be male, or female (non childbearing potential or using adequate contraception)

- Have a body mass index between 18 and 29 kg/m2

- Able to understand the study and give written informed consent

- Be determined healthy based on a medical and laboratory evaluation

Exclusion Criteria:

- Patients under the age of 18 years or over 40 years of age

- Current smoker or history of smoking within 3 months of participation

- Inability to comprehend study and provide written informed consent

- Inability to comply with the study requirements

- History of or current evidence of major organ disease

- Renal disease - serum creatinine > 1.5 mg/dL, significant hematuria or proteinuria,
known structural abnormality or chronic kidney disease

- Hepatic disease - active viral hepatitis, history of hepatitis B or hepatitis C,
bilirubin > 2.0, ALT or AST above normal upper limit for laboratory, alcoholic liver
disease, other chronic liver disease

- CNS disease or cognitive dysfunction - any past history of epilepsy, CNS infections,
stroke, CNS bleed, severe headaches, major psychiatric illness, or current mental
status changes

- Lung disease - history of severe asthma, COPD, pulmonary tuberculosis, or other major
lung disease

- Cardiac disease - history or current evidence of ischemic coronary artery disease,
myocardial infarction, heart failure, or significant arrhythmia

- Gastrointestinal disease - presence of inflammatory bowel disease, difficulty
swallowing, or any gastrointestinal probably that would limit taking oral medications
or that may compromise absorption of oral medications

- Cancer - History of hematologic malignancy or solid tumor excluding basal cell
carcinoma limited to the skin within the past 5 years

- History of autoimmune or inflammatory disease such as rheumatoid arthritis and lupus

- Immunocompromised state - solid organ transplant, cancer chemotherapy, stem cell
transplant with graft versus host disease, immunosuppressive therapy, or HIV
infection

- Recent weight loss of greater than 10%

- Any other history or evidence of disease that in the opinion of the physician would
increase the risk for the subject for clinical trial participation

- Regular use of prescription medications, over-the-counter medications, or
dietary/herbal supplements within 14 days of day 1. Occasional use of acetaminophen
or over-the-counter NSAID within the 14 day window may be allowed at the P.I.
discretion

- Subjects who received another investigational drug within 30 days of enrollment