Comparison of Nikkomycin Z Bioavailability Under Fed and Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate if eating a high fat meal versus not eating any food affects how the study drug (Nikkomycin Z) is absorbed into the body. The second purpose is to gain further information about the safety of Nikkomycin Z in healthy adults.

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

Official Title
-----------------
Comparison of Nikkomycin Z Bioavailability After Single Dose Administration Under Fed (High Fat Meal) Compared to Fasting Conditions

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Nikkomycin Z


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nikkomycin Z fed - fasting<br>Period 1: Day 1: Nikkomycin Z 500 mg with high fat breakfast Period 2: Day 1: Nikkomycin Z 500 mg under fasted conditions | Drug: Nikkomycin Z<br>* Capsule, 500 mg, single-dose<br>|
| Experimental: Nikkomycin Z fasting - fed<br>Period 1: Day 1: Nikkomycin Z 500 mg under fasted conditions Period 2: Day 1: Nikkomycin Z 500 mg with high fat breakfast | Drug: Nikkomycin Z<br>* Capsule, 500 mg, single-dose<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate and extent of Nikkomycin Z absorption under fed and fasting conditions |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of Nikkomycin Z urinary excretion |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bioavailability, Fed, Fasting