Comparison of Nikkomycin Z Bioavailability Under Fed and Fasting Conditions

University of Arizona

Status and phase

Terminated

Phase 1

Conditions

Healthy

Treatments

Drug: Nikkomycin Z

Study type

Interventional

Funder types

Other

Identifiers

NCT01647256

VFCE-2011-004

Details and patient eligibility

About

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.

Full description

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

Enrollment

5 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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