Toxicokinetic Study of Dichlorobisphenol A After an Oral or Dermal Single Dose in Healthy Volunteer. — PRECEPT  

Pharmacokinetic Study Clinical Trial

Official title: Toxicokinetic Study of Dichlorobisphenol A After an Oral or Dermal Single Dose in Healthy Volunteer.

Status Recruiting

Clinical Trial Summary

The objective of this study is to determine toxicokinetic parameters of deuterated d12-Cl2BPA after the administration of a single low dose (50 µg/kg) to healthy volunteers via oral or dermal routes.

Clinical Trial Description

Dichlorobisphenol A (Cl2BPA)is formed by the reaction of chlorine with bisphenol A present in water during water disinfection process. As a consequence, Cl2BPA is present in various aqueous media including tap water. Cl2BPA has also been found in human, in blood, urine, breast milk and adipose tissue suggesting chronic exposure to this compound. Cl2BPA is an endocrine disruptor that binds to estrogenic and PPAR-γ receptors. Epidemiological studies have shown that exposure to DCBPA has been related to the occurrence of diabetes, obesity and myocardial infarction.

Currently, no toxicokinetic data are available to estimate the disposition (ADME) of Cl2BPA after oral and dermal exposure in human while these data are needed for proper risk assessment of this compound.

The objective of this study is to determine toxicokinetic parameters of deuterated d12-Cl2BPA after the administration of a single low dose (50 µg/kg) to healthy volunteers via oral or dermal routes. ;

Related Conditions & MeSH terms

• Pharmacokinetic Study

• NCT number: NCT04788810
• Study type: Interventional
• Source: Poitiers University Hospital
• Contact: Nicolas Venisse, PhD, PharmD
• Phone: +33549444980
• Email: nicolas.venisse@chu-poitiers.fr
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Completion date: September 2022