Safety and PK of Nikkomycin Z in Healthy Subjects
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to determine if nikkomycin Z is safe when administered at different dose levels for 14 days. The study will also determine blood levels and urinary excretion of nikkomycin Z in relation to dose administered. Healthy patients will be eligible to participate and will be allocated to receive nikkomycin Z (various doses) or a placebo.
Full description
This protocol will serve as a Phase I, randomized, double-blind, placebo controlled, multiple-dose study to evaluate the safety, tolerance and pharmacokinetics of nikkomycin Z. Nikkomycin Z has previously been studied in a single dose protocol in healthy male subjects. This study is designed to run in parallel to protocol VFCE-2007-001 to provide additional data on safety and pharmacokinetics. The study will involve a total of 32 subjects (6 active/2 placebo per group) with a multiple, rising dose strategy.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Age >= 18 years and <= 40 years
- Male or Female (if female, must have a negative pregnancy test and agrees to use an acceptable contraception method)
- Able to understand 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
- 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 including:
- 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, significant arrhythmia
- Gastrointestinal disease - presence of inflammatory bowel disease, difficulty swallowing, or any gastrointestinal problem 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
- 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
- Immunocompromised state - solid organ transplant, cancer chemotherapy, BMT with graft versus host disease, immunosuppressive therapy, or HIV infection
- Recent weight loss of greater than 10%
- 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.'s discretion
- Subjects who received another investigational drug within 30 days of enrollment
Trial design
Primary purpose
Allocation
Interventional model
Masking
32 participants in 4 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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