Safety and PK of Nikkomycin Z in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: nikkomycin Z

• Registration Number: NCT00834184
• Lead Sponsor: University of Arizona

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-02-02
• Study First Submitted QC: 2009-02-02
• Study First Posted: 2009-02-03
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-18
• Last Update Posted: 2020-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
A	nikkomycin Z	nikkomycin Z 250 mg BID versus placebo BID x 14 days
C	nikkomycin Z	nikkomycin Z 750 mg BID versus placebo BID x 14 days
D	nikkomycin Z	nikkomycin Z 750 mg TID versus placebo TID x 14 days
B	nikkomycin Z	nikkomycin Z 500 mg BID versus placebo BID x 14 days

Primary Outcome Measures

Name	Time	Method
Determine safety and tolerance of nikkomycin Z in healthy subjects following administration of multiple doses.	four weeks

Secondary Outcome Measures

Name	Time	Method
Evaluate the multiple dose pharmacokinetics of nikkomycin Z in healthy subjects	two weeks

Trial Locations

Locations (1)

Clinical & Translational Research Center - University of Arizona; 🇺🇸 Tucson, Arizona, United States