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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pharmacokinetic Study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Oral route = 6 volunteers Dermal route = 6 volunteers

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Oral route

Volunteers receiving d12-Cl2BPA via oral route

Group Type EXPERIMENTAL

Administration of d12-Cl2BPA

Intervention Type OTHER

Administration of d12-Cl2BPA

Dermal route

Volunteers receiving d12-Cl2BPA via oral route

Group Type EXPERIMENTAL

Administration of d12-Cl2BPA

Intervention Type OTHER

Administration of d12-Cl2BPA

Interventions

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Administration of d12-Cl2BPA

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

51 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes