Pharmacokinetics of Advantage Arrest in Children

NCT04186663 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 2019-06-23
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to characterize basic PK parameters (Cmax, t1/2, AUC) in healthy children to contribute to evidence for the safety of Advantage Arrest, consistent with Guidance for Industry--Exposure--Response Relationships (April 2003).

Conditions

Dental Caries

Keywords

child; pharmacokinetics; silver diamine fluoride

Outcome Measures

Primary Outcomes (3)

• Predicted Peak Serum Silver Concentration (Cmax)

  As only a single blood sample was obtained from each child, serum silver concentration versus time data were analyzed simultaneously using population pharmacokinetic analysis with nonlinear mixed effects modeling. The parameters estimated were the apparent volume of distribution (V/F) and apparent oral clearance (CL/F). The rate constant of absorption (ka) was fixed to 23.7 day-1. The predicted peak serum silver Cmax was calculated using Cmax = Dose/(V/F)\*exp\^(-k⋅tmax ), where k = (CL/F)/(V/F) and tmax = \[ln(ka/k)\]/(ka-k).

  Based on data collected at 2, 4, 6, 24, 48, 96, and 168 hours post-SDF application

• Predicted Time to Peak Serum Silver Concentration (Tmax)

  As only a single blood sample was obtained from each child, serum silver concentration versus time data were analyzed simultaneously using population pharmacokinetic analysis with nonlinear mixed effects modeling. The parameters estimated were the apparent volume of distribution (V/F) and apparent oral clearance (CL/F). The rate constant of absorption (ka) was fixed to 23.7 day-1. The predicted time to peak concentration was calculated using tmax = \[ln(ka/k)\]/(ka-k), where k = (CL/F)/(V/F).

  Based on data collected at 2, 4, 6, 24, 48, 96, and 168 hours post-SDF application

• Silver Half-life

  As only a single blood sample was obtained from each child, serum silver concentration versus time data were analyzed simultaneously using population pharmacokinetic analysis with nonlinear mixed effects modeling. The parameters estimated were the apparent volume of distribution (V/F) and apparent oral clearance (CL/F). The rate constant of absorption (ka) was fixed to 23.7 day-1. The half-life of silver was calculated using half-life = ln(2)/k, where k = (CL/F)/(V/F).

  Based on data collected at 2, 4, 6, 24, 48, 96, and 168 hours post-SDF application

Secondary Outcomes (3)

• Apparent Oral Clearance of Silver (CL/F)

  Based on data collected at 2, 4, 6, 24, 48, 96, and 168 hours post-SDF application

• Apparent Volume of Distribution of Silver (V/F)

  Based on data collected at 2, 4, 6, 24, 48, 96, and 168 hours post-SDF application

• Serum Silver Exposure (AUC)

  Based on data collected at 2, 4, 6, 24, 48, 96, and 168 hours post-SDF application

Other Outcomes (1)

• Average Serum Fluoride Concentrations

  Collected at 2, 4, 6, 24, 48, 96, and 168 hours post-SDF application

Study Arms (1)

Advantage Arrest

EXPERIMENTAL

38% silver diamine fluoride, topical, 1 drop, single application

Drug: Silver Diamine Fluoride

Interventions

Silver Diamine Fluoride DRUG

38% aqueous silver diamine fluoride \[Ag(NH3)\]2F, CAS RN 33040-28-7

Also known as: Advantage Arrest

Advantage Arrest

Eligibility Criteria

• Age: 3 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy.
• At least one carious lesion.

You may not qualify if:

• Oral mucositis
• Any ulcerative lesions
• Hypersensitivity to silver
• Hypersensitivity to fluoride.
• SDF treatment within 3 months.

Sponsors & Collaborators

• Advantage Silver Dental Arrest, LLC: lead
• University of California, San Francisco: collaborator

Study Sites (1)

University of California San Francisco Clinical and Translational Science Institute

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Dental Caries

Interventions

silver diamine fluoride

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Dr. Hellene Ellenikiotis
• Organization: University of California San Francisco

hellene.ellenikiotis@ucsf.edu

408-313-0166

Study Officials

• Hellene Ellenikiotis, DDS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label exposure--response study

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 5, 2019
• Study Start: August 1, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: March 10, 2022
• Results First Posted: March 10, 2022

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)