Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_1 healthy

Timeline

Completed

Started Jul 2011

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4 months study duration

Study Start

First participant enrolled

July 1, 2011

Completed

18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2011

Completed

10 days until next milestone

First Posted

Study publicly available on registry

July 29, 2011

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed

4 years until next milestone

Results Posted

Study results publicly available

October 26, 2015

Completed

Last Updated

July 4, 2016

Status Verified

September 1, 2015

Enrollment Period

4 months

First QC Date

July 19, 2011

Results QC Date

July 12, 2013

Last Update Submit

May 25, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (31)

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 Outcomes (4)

Cytochrome P450 Assay on Chlorozoxazone in Participants Dosed With Silver
14 Days
Total Change in Systolic Blood Pressure Silver Participants
Baseline and 14 Days
Total Change in Diastolic Blood Pressure Silver Participants
Baseline and 14 Days
Total Change in Heart Rate in Silver Participants
Baseline and 14 Days

Study Arms (2)

32ppm Oral Silver

EXPERIMENTAL

14 Days Active Silver Solution

Drug: 32ppm Silver Particle

Sterile Water

PLACEBO COMPARATOR

No Silver Nanoparticles

Drug: Placebo

Interventions

32ppm Silver ParticleDRUG

Oral silver dose of 32ppm

32ppm Oral Silver

PlaceboDRUG

Sterile Water No Silver

Sterile Water

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

years old without debilitating chronic disease or history of cardiovascular event.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

University of Utahlead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112-5820, United States

Location

Related Publications (1)

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.
PMID: 23811290DERIVED

Results Point of Contact

Title: Dr. Mark Munger
Organization: University of Utah

Study Officials

Mark Munger, Pharm.D.
University of Utah
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

July 19, 2011

First Posted

July 29, 2011

Study Start

July 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

July 4, 2016

Results First Posted

October 26, 2015

Record last verified: 2015-09

Locations

US(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (31)

Secondary Outcomes (4)

Study Arms (2)

32ppm Oral Silver

Sterile Water

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations