Comparison of Nikkomycin Z Bioavailability Under Fed and Fasting Conditions

This is an interventional basic science trial for Healthy focused on measuring Bioavailability, Fed, Fasting Read More

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