Safety and PK of Nikkomycin Z in Healthy Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00834184

Run by

University of Arizona

People needed

32

Starts

2008-10-01

Expected to finish

2009-09-01

Last updated by the study team

2020-11-23

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical & Translational Research Center - University of Arizona — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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