Clinical trial NCT01405794: In-Vivo Assessment of Silver Biomaterial Nano-Toxicity 32 Ppm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2011-07-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change Sodium Blood Levels
timeFrame: 14 Days
measure: Change Potassium Blood Levels
timeFrame: 14 days
measure: Change in Chloride Blood Levels
timeFrame: 14 days
measure: Change in Carbon Dioxide Blood Levels
timeFrame: 14 days
measure: Change In Urea Nitrogen Blood Levels
timeFrame: 14 days
measure: Change In Creatinine Blood Levels
timeFrame: 14 Days
measure: Change In Glucose Blood Levels
timeFrame: 14 Days
measure: Change In Alkaline Phosphatase Blood Level
timeFrame: 14 Days
measure: Change In Aspartate Aminotransferase Blood Level
timeFrame: 14 Days
measure: Change In Alanine Aminotransferase Blood Level
timeFrame: 14 Days
measure: Change in Total Protein Blood Levels
timeFrame: 14 Days
measure: Change In Total Bilirubin Blood Levels
timeFrame: 14 Days
measure: Change In Albumin Blood Levels
timeFrame: 14 Days
measure: Change In Calcium Blood Level
timeFrame: 14 Days
measure: Change In White Blood Count Blood Levels
timeFrame: 14 Days
measure: Change In Red Blood Count Blood Levels
timeFrame: 14 Days
measure: Change In Hemoglobin Blood Levels
timeFrame: 14 Days
measure: Change In Hematocrit Blood Levels
timeFrame: 14 Days
measure: Change In Mean Corpuscular Volume Blood Levels
timeFrame: 14 Days
measure: Change In Mean Corpuscular Hemoglobin Concentration Blood Levels
timeFrame: 14 Days
measure: Change In Platelet Blood Levels
timeFrame: 14 Days
measure: Change In Granulocytes Blood Levels
timeFrame: 14 Days
measure: Change In Lymphocytes Blood Levels
timeFrame: 14 Days
measure: Change In Monocytes Blood Levels
timeFrame: 14 Days
measure: Change In Basophils Blood Levels
timeFrame: 14 Days
measure: Change In Eosinophils Blood Levels
timeFrame: 14 Days
measure: Cytochrome P450 Assay on Dextromethorphan in Participants
timeFrame: 14 Days
measure: Cytochrome P450 Assay on Losartan in Participants
timeFrame: 14 Days
measure: Cytochrome P450 Assay on Caffeine in Participants
timeFrame: 14 Days
measure: Cytochrome P450 Assay on Omeprazole in Participants
timeFrame: 14 Days
measure: Cytochrome P450 Assay on Midazolam in Participants
timeFrame: 14 Days
Secondary outcomes:
measure: Cytochrome P450 Assay on Chlorozoxazone in Participants Dosed With Silver
timeFrame: 14 Days
measure: Total Change in Systolic Blood Pressure Silver Participants
timeFrame: Baseline and 14 Days
measure: Total Change in Diastolic Blood Pressure Silver Participants
timeFrame: Baseline and 14 Days
measure: Total Change in Heart Rate in Silver Participants
timeFrame: Baseline and 14 Days
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Mark Munger, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Munger MA, Radwanski P, Hadlock GC, Stoddard G, Shaaban A, Falconer J, Grainger DW, Deering-Rice CE. In vivo human time-exposure study of orally dosed commercial silver nanoparticles. Nanomedicine. 2014 Jan;10(1):1-9. doi: 10.1016/j.nano.2013.06.010. Epub 2013 Jun 28.