NCT01243320|CompletedPhase 1/2ResultsDMC
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Sponsor study identifier
interventional
36
1 country
1
Study Start
December 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2011
Actual (reported)Study Completion
July 2011
Actual (reported)Nanotechnology is the controlled generation and manipulation of matter in dimensions less than 100 nm. Silver has been used for its bactericidal properties. The investigators propose to study the American Biotech Laboratory 32 ppm silver solution over a 14-day period in human volunteers to determine the toxicity and to quantify cytochrome P450 enzyme effects of this solution.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 16, 2010
Actual (reported)November 18, 2010
Actual (reported)December 2010
Date type not reportedThis date has not been verified as actual or estimated.
July 2011
Actual (reported)July 2011
Actual (reported)August 25, 2015
Actual (reported)Change in Sodium Blood Levels
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change in Potassium Blood Levels
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change in Chloride Blood Levels
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change in Carbon Dioxide Blood Levels
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change in Urea Nitrogen Blood Levels
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In CreatinineBlood Levels
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Glucose Blood Levels
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Alkaline Phosphatase Blood Level
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Aspartate Aminotransferase Blood Level
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Alanine Aminotransferase Blood Level
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Total Protein Blood Levels
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Total Bilirubin Blood Levels
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change in Albumin Blood Levels
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Calcium Blood Level
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In White Blood Count Blood Levels
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Red Blood Count Blood Levels
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Hemoglobin Blood Levels
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Hematocrit Blood Levels
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Mean Corpuscular Volume Blood Levels
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 days
Change In Mean Corpuscular Hemoglobin Blood Levels
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Mean Corpuscular Hemoglobin Concentration Blood Levels
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 days
Change In Platelet Blood Levels
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Granulocytes Blood Levels
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Lymphocytes Blood Levels
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Monocytes Blood Levels
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change in Basophils Blood Levels
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change in Eosinophil Blood Levels
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Sputum Reactive Oxygen Species Change
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change to Interleukin-8 Receptor
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change to Interleukin-1 Alpha Receptor
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change to Interleukin-1 Beta Receptor
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change in Monocyte Chemotactic Protein 1
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change in Quinone Oxidoreductase 1 Gene
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change Systolic Blood Pressure
14 Days
Mean Change in Diastolic Blood Pressure
14 Days
Mean Change in Heart Rate
14 Days
Oral Dose of 10ppm
Oral Dose of 32ppm
Silver nanoparticles at 10ppm
Silver nanoparticles at 32ppm
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Utah Hospital and Clinics
Salt Lake City, Utah, 84132, United States
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.
Mark A Munger, Pharm.D>
University of Utah
36 participants (actual enrollment reported by the registry).
First Submitted
November 16, 2010
First Posted
November 18, 2010
Study Start
December 2010
Date type not reportedThis date has not been verified as actual or estimated.
Study to Evaluate the Pharmacokinetics and Safety of INX-08189 Administered With VictrelisTM in Healthy Subjects
Contact the study team to confirm eligibility.
Primary Completion
July 2011
Actual (reported)Study Completion
July 2011
Actual (reported)Last Updated
August 25, 2015
Results First Posted
August 25, 2015
Record last verified: 2015-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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