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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01405794

Enrollment

Registered

2011-07-29

Start date

2011-07-31

Completion date

2011-11-30

Last updated

2016-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

The investigators propose to study oral commercial silver nanoparticle products on human enzyme activity.

Interventions

DRUG32ppm Silver Particle

Oral silver dose of 32ppm

DRUGPlacebo

Sterile Water No Silver

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Cytochrome P450 Assay on Midazolam in Participants	14 Days	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.
Cytochrome P450 Assay on Dextromethorphan in Participants	14 Days	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.
Cytochrome P450 Assay on Losartan in Participants	14 Days	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.
Cytochrome P450 Assay on Caffeine in Participants	14 Days	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.
Cytochrome P450 Assay on Omeprazole in Participants	14 Days	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.
Change In Calcium Blood Level	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In White Blood Count Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Red Blood Count Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Hemoglobin Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Hematocrit Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change Sodium Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change Potassium Blood Levels	14 days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change in Chloride Blood Levels	14 days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change in Carbon Dioxide Blood Levels	14 days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Urea Nitrogen Blood Levels	14 days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Creatinine Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Glucose Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Alkaline Phosphatase Blood Level	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Aspartate Aminotransferase Blood Level	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Alanine Aminotransferase Blood Level	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change in Total Protein Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Total Bilirubin Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Albumin Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Mean Corpuscular Volume Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Mean Corpuscular Hemoglobin Concentration Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Platelet Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Granulocytes Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Lymphocytes Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Monocytes Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Basophils Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Eosinophils Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)

Secondary

Measure	Time frame	Description
Total Change in Systolic Blood Pressure Silver Participants	Baseline and 14 Days	Assessment only completed on the 32ppm Oral Silver part of the trail
Total Change in Diastolic Blood Pressure Silver Participants	Baseline and 14 Days	Assessment only completed on the 32ppm Oral Silver part of the trail
Total Change in Heart Rate in Silver Participants	Baseline and 14 Days	Assessment only completed on the 32ppm Oral Silver part of the trail
Cytochrome P450 Assay on Chlorozoxazone in Participants Dosed With Silver	14 Days	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
All Participants	12
Total	12

Baseline characteristics

Characteristic	All Participants
Age, Continuous	28.8 years
Sex: Female, Male Female	0 Participants
Sex: Female, Male Male	12 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 12	0 / 12
serious Total, serious adverse events	0 / 12	1 / 12