Clinical trial NCT04788810: Toxicokinetic Study of Dichlorobisphenol A After an Oral or Dermal Single Dose in Healthy Volunteer.
Official title: Toxicokinetic Study of Dichlorobisphenol A After an Oral or Dermal Single Dose in Healthy Volunteer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pharmacokinetic Study
Keywords: Toxicokinetics
Endocrine Disruptors
Bisphenol A derivatives
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Oral route = 6 volunteers Dermal route = 6 volunteers
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: Hour 0-Hour 24
measure: Cmax
timeFrame: Hour 0-Hour 24
measure: Total clearance
timeFrame: Hour 0 - Hour 24
measure: Volume of distribution
timeFrame: Hour 0 - Hour 24
Secondary outcomes:
measure: Secondary toxicokinetic parameters
timeFrame: Hour 0 - Hour 24
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CIC Poitiers
Study officials:
References: