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

Not Applicable

• Conditions: Pharmacokinetic Study
• Interventions: Other: Administration of d12-Cl2BPA

• Registration Number: NCT04788810
• Lead Sponsor: Poitiers University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2021-03
• Study Start: 2021-03-01
• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-03-05
• Study First Posted: 2021-03-09
• Last Update Submitted: 2021-03-31
• Last Update Posted: 2021-04-05
• Primary Completion: 2022-03
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

• Age 18-51 year old
• No current disease
• BMI range: 18.5-24.9 kg/m²,
• Non smoker
• Normal renal function
• Normal hepatic function
• Normal gastrointestinal function
• Affiliated to national health insurance
• Having signed an informed consent

Exclusion Criteria

• Renal function ≤ 90 ml/min/1.73 m² (CKD-EPI)
• Altered hepatic function ASAT > 50 UI/L and/or ALAT > 50 UI/L,
• Current disease,
• Heavy alcohol consumption
• No treatment susceptible to alter Cl2BPA toxicokinetics (drugs that interact with metabolic enzymes or transporter proteins,, anti-acids, etc)
• Pregnant women, lactating mothers and women of childbearing potential with no reliable medical contraception

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dermal route	Administration of d12-Cl2BPA	Volunteers receiving d12-Cl2BPA via oral route
Oral route	Administration of d12-Cl2BPA	Volunteers receiving d12-Cl2BPA via oral route

Primary Outcome Measures

Name	Time	Method
Total clearance	Hour 0 - Hour 24	Non-compartmental and compartmental toxicokinetic analysis
Cmax	Hour 0-Hour 24	Non-compartmental and compartmental toxicokinetic analysis
Volume of distribution	Hour 0 - Hour 24	Non-compartmental and compartmental toxicokinetic analysis
Area under the plasma concentration versus time curve (AUC)	Hour 0-Hour 24	Non-compartmental and compartmental toxicokinetic analysis

Secondary Outcome Measures

Name	Time	Method
Secondary toxicokinetic parameters	Hour 0 - Hour 24	half-life

Trial Locations

Locations (1)

CIC Poitiers; 🇫🇷 Poitiers, France