In-Vivo Assessment of Silver Biomaterial Nano-Toxicity 32 Ppm
25. mai 2016 oppdatert av: mark munger, University of Utah
The investigators propose to study oral commercial silver nanoparticle products on human enzyme activity.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
12
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Utah
-
Salt Lake City, Utah, Forente stater, 84112-5820
- University of Utah
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 32ppm Oral Silver
14 Days Active Silver Solution
|
Oral silver dose of 32ppm
|
|
Placebo komparator: Sterile Water
No Silver Nanoparticles
|
Sterile Water No Silver
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change Sodium Blood Levels
Tidsramme: 14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change Potassium Blood Levels
Tidsramme: 14 days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 days
|
|
Change in Chloride Blood Levels
Tidsramme: 14 days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 days
|
|
Change in Carbon Dioxide Blood Levels
Tidsramme: 14 days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 days
|
|
Change In Urea Nitrogen Blood Levels
Tidsramme: 14 days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 days
|
|
Change In Creatinine Blood Levels
Tidsramme: 14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Glucose Blood Levels
Tidsramme: 14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Alkaline Phosphatase Blood Level
Tidsramme: 14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Aspartate Aminotransferase Blood Level
Tidsramme: 14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Alanine Aminotransferase Blood Level
Tidsramme: 14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change in Total Protein Blood Levels
Tidsramme: 14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Total Bilirubin Blood Levels
Tidsramme: 14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Albumin Blood Levels
Tidsramme: 14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Calcium Blood Level
Tidsramme: 14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In White Blood Count Blood Levels
Tidsramme: 14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Red Blood Count Blood Levels
Tidsramme: 14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Hemoglobin Blood Levels
Tidsramme: 14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Hematocrit Blood Levels
Tidsramme: 14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Mean Corpuscular Volume Blood Levels
Tidsramme: 14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Mean Corpuscular Hemoglobin Concentration Blood Levels
Tidsramme: 14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Platelet Blood Levels
Tidsramme: 14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Granulocytes Blood Levels
Tidsramme: 14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Lymphocytes Blood Levels
Tidsramme: 14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Monocytes Blood Levels
Tidsramme: 14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Basophils Blood Levels
Tidsramme: 14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Change In Eosinophils Blood Levels
Tidsramme: 14 Days
|
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
|
14 Days
|
|
Cytochrome P450 Assay on Dextromethorphan in Participants
Tidsramme: 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.
|
14 Days
|
|
Cytochrome P450 Assay on Losartan in Participants
Tidsramme: 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.
|
14 Days
|
|
Cytochrome P450 Assay on Caffeine in Participants
Tidsramme: 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.
|
14 Days
|
|
Cytochrome P450 Assay on Omeprazole in Participants
Tidsramme: 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.
|
14 Days
|
|
Cytochrome P450 Assay on Midazolam in Participants
Tidsramme: 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.
|
14 Days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Cytochrome P450 Assay on Chlorozoxazone in Participants Dosed With Silver
Tidsramme: 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.
|
14 Days
|
|
Total Change in Systolic Blood Pressure Silver Participants
Tidsramme: Baseline and 14 Days
|
Assessment only completed on the 32ppm Oral Silver part of the trail
|
Baseline and 14 Days
|
|
Total Change in Diastolic Blood Pressure Silver Participants
Tidsramme: Baseline and 14 Days
|
Assessment only completed on the 32ppm Oral Silver part of the trail
|
Baseline and 14 Days
|
|
Total Change in Heart Rate in Silver Participants
Tidsramme: Baseline and 14 Days
|
Assessment only completed on the 32ppm Oral Silver part of the trail
|
Baseline and 14 Days
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Mark Munger, Pharm.D., University of Utah
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juli 2011
Primær fullføring (Faktiske)
1. november 2011
Studiet fullført (Faktiske)
1. november 2011
Datoer for studieregistrering
Først innsendt
19. juli 2011
Først innsendt som oppfylte QC-kriteriene
28. juli 2011
Først lagt ut (Anslag)
29. juli 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
4. juli 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. mai 2016
Sist bekreftet
1. september 2015
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 50310 (MSD Sharp&Dohme GmbH)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .