In-Vivo Assessment of Silver Biomaterial Nano-Toxicity 32 Ppm

Study Overview
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Brief Summary
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The investigators propose to study oral commercial silver nanoparticle products on human enzyme activity.

Conditions
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Healthy

Intervention / Treatment
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* Drug: 32ppm Silver Particle
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-80 years old without debilitating chronic disease or history of cardiovascular event. Exclusion Criteria: Women physically capable of becoming pregnant, who are not using 2 barrier methods of birth control; Any female who is nursing; History of heavy metal allergy; History of asthma or Chronic Obstructive Pulmonary Disease; History of renal impairment; Symptoms of active upper respiratory disease at time of consent; Smoking more than 5 cigarettes or equivalent and not able to stop for 48 hours; Ability to discontinue chronic medications or nutraceuticals for 20 days or 5 half-lives of the agent, whichever is longer.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 32ppm Oral Silver<br>14 Days Active Silver Solution | Drug: 32ppm Silver Particle<br>* Oral silver dose of 32ppm<br>|
| Placebo Comparator: Sterile Water<br>No Silver Nanoparticles | Drug: Placebo<br>* Sterile Water No Silver<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change Sodium Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days | 
| Change Potassium Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 days | 
| Change in Chloride Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 days | 
| Change in Carbon Dioxide Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 days | 
| Change In Urea Nitrogen Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 days | 
| Change In Creatinine Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days | 
| Change In Glucose Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days | 
| Change In Alkaline Phosphatase Blood Level | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days | 
| Change In Aspartate Aminotransferase Blood Level | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days | 
| Change In Alanine Aminotransferase Blood Level | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days | 
| Change in Total Protein Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days | 
| Change In Total Bilirubin Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days | 
| Change In Albumin Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days | 
| Change In Calcium Blood Level | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days | 
| Change In White Blood Count Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days | 
| Change In Red Blood Count Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days | 
| Change In Hemoglobin Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days | 
| Change In Hematocrit Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days | 
| Change In Mean Corpuscular Volume Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days | 
| Change In Mean Corpuscular Hemoglobin Concentration Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days | 
| Change In Platelet Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days | 
| Change In Granulocytes Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days | 
| Change In Lymphocytes Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days | 
| Change In Monocytes Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days | 
| Change In Basophils Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days | 
| Change In Eosinophils Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days | 
| Cytochrome P450 Assay on Dextromethorphan in Participants | Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm. | 14 Days | 
| Cytochrome P450 Assay on Losartan in Participants | Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm. | 14 Days | 
| Cytochrome P450 Assay on Caffeine in Participants | Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm. | 14 Days | 
| Cytochrome P450 Assay on Omeprazole in Participants | Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm. | 14 Days | 
| Cytochrome P450 Assay on Midazolam in Participants | Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm. | 14 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytochrome P450 Assay on Chlorozoxazone in Participants Dosed With Silver | Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm. | 14 Days | 
| Total Change in Systolic Blood Pressure Silver Participants | Assessment only completed on the 32ppm Oral Silver part of the trail | Baseline and 14 Days | 
| Total Change in Diastolic Blood Pressure Silver Participants | Assessment only completed on the 32ppm Oral Silver part of the trail | Baseline and 14 Days | 
| Total Change in Heart Rate in Silver Participants | Assessment only completed on the 32ppm Oral Silver part of the trail | Baseline and 14 Days |