Clinical trial NCT04186663: Pharmacokinetics of Advantage Arrest in Children
Official title: Pharmacokinetics of Advantage Arrest in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Caries
Keywords: child
pharmacokinetics
silver diamine fluoride
Lead sponsor: Advantage Silver Dental Arrest, LLC
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
First posted: 2019-12-05
Enrollment: 59
Sex: ALL
Minimum age (years): 3
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label exposure--response study
Primary purpose: TREATMENT

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).

Detailed description: This is a topical agent where the active ingredients are applied to the teeth and eventually swallowed and may be absorbed through the GI tract or excreted. Minimal amounts are absorbed through the oral mucosa. Serum concentrations of silver and fluoride will be be proportional to the dose of silver and fluoride administered topically to the teeth as part of Advantage Arrest. This is an open label exposure-response study with up to 50 healthy children ages 3-13 years of age. Subjects will be treated with Advantage Arrest and have one blood sample withdrawn at a randomly assigned time point. A minimum of 3 subjects per time point at 2,4,6,24,48,96 and 168 hours. Serum samples will be analyzed for F and Ag.

Eligibility criteria: Inclusion Criteria:

* Healthy.
* At least one carious lesion.

Exclusion Criteria:

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

Primary outcomes:
measure: Predicted Peak Serum Silver Concentration (Cmax)
timeFrame: Based on data collected at 2, 4, 6, 24, 48, 96, and 168 hours post-SDF application
measure: Predicted Time to Peak Serum Silver Concentration (Tmax)
timeFrame: Based on data collected at 2, 4, 6, 24, 48, 96, and 168 hours post-SDF application
measure: Silver Half-life
timeFrame: Based on data collected at 2, 4, 6, 24, 48, 96, and 168 hours post-SDF application
Secondary outcomes:
measure: Apparent Oral Clearance of Silver (CL/F)
timeFrame: Based on data collected at 2, 4, 6, 24, 48, 96, and 168 hours post-SDF application
measure: Apparent Volume of Distribution of Silver (V/F)
timeFrame: Based on data collected at 2, 4, 6, 24, 48, 96, and 168 hours post-SDF application
measure: Serum Silver Exposure (AUC)
timeFrame: Based on data collected at 2, 4, 6, 24, 48, 96, and 168 hours post-SDF application
Other outcomes:
measure: Average Serum Fluoride Concentrations
timeFrame: Collected at 2, 4, 6, 24, 48, 96, and 168 hours post-SDF application
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco Clinical and Translational Science Institute
state: California
Study officials:
affiliation: University of California, San Francisco
name: Hellene Ellenikiotis, DDS
role: PRINCIPAL_INVESTIGATOR
References: