Pharmacokinetic Study
Conditions
Keywords
Toxicokinetics, Endocrine Disruptors, Bisphenol A derivatives
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.
Interventions
OTHERAdministration of d12-Cl2BPA
Administration of d12-Cl2BPA
Sponsors
Poitiers University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Oral route = 6 volunteers Dermal route = 6 volunteers
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 51 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) | Hour 0-Hour 24 | Non-compartmental and compartmental toxicokinetic analysis |
| Cmax | Hour 0-Hour 24 | Non-compartmental and compartmental toxicokinetic analysis |
| Total clearance | Hour 0 - Hour 24 | Non-compartmental and compartmental toxicokinetic analysis |
| Volume of distribution | Hour 0 - Hour 24 | Non-compartmental and compartmental toxicokinetic analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary toxicokinetic parameters | Hour 0 - Hour 24 | half-life |
Countries
France
Contacts
Primary ContactNicolas Venisse, PhD, PharmD
Outcome results
None listed