Phase I, Randomized, Double-blind, Placebo Controlled, Multiple-dose Evaluation of the Safety Tolerance and Pharmacokinetics of Nikkomycin Z in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Determine safety and tolerance of nikkomycin Z in healthy subjects following administration of multiple doses.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
A
nikkomycin Z 250 mg BID versus placebo BID x 14 days
干预措施: nikkomycin Z (Drug)
B
nikkomycin Z 500 mg BID versus placebo BID x 14 days
干预措施: nikkomycin Z (Drug)
C
nikkomycin Z 750 mg BID versus placebo BID x 14 days
干预措施: nikkomycin Z (Drug)
D
nikkomycin Z 750 mg TID versus placebo TID x 14 days
干预措施: nikkomycin Z (Drug)
结局指标
主要结局
Determine safety and tolerance of nikkomycin Z in healthy subjects following administration of multiple doses.
时间窗: four weeks
次要结局
- Evaluate the multiple dose pharmacokinetics of nikkomycin Z in healthy subjects(two weeks)