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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral route | Experimental | Volunteers receiving d12-Cl2BPA via oral route |
|
| Dermal route | Experimental | Volunteers receiving d12-Cl2BPA via oral route |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of d12-Cl2BPA | Other | Administration of d12-Cl2BPA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) | Non-compartmental and compartmental toxicokinetic analysis | Hour 0-Hour 24 |
| Cmax | Non-compartmental and compartmental toxicokinetic analysis | Hour 0-Hour 24 |
| Total clearance | Non-compartmental and compartmental toxicokinetic analysis | Hour 0 - Hour 24 |
| Volume of distribution | Non-compartmental and compartmental toxicokinetic analysis | Hour 0 - Hour 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary toxicokinetic parameters | half-life | Hour 0 - Hour 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas Venisse, PhD, PharmD | Contact | +33549444980 | nicolas.venisse@chu-poitiers.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIC Poitiers | Recruiting | Poitiers | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36649713 | Derived | Plattard N, Gnanasegaran R, Krekesheva A, Carato P, Dupuis A, Migeot V, Albouy M, Haddad S, Venisse N. Quantification of the Conjugated Forms of Dichlorobisphenol A (3,3'-Cl 2 BPA) in Rat and Human Plasma Using HPLC-MS/MS. Ther Drug Monit. 2023 Aug 1;45(4):554-561. doi: 10.1097/FTD.0000000000001074. Epub 2023 Jan 16. |
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Oral route = 6 volunteers Dermal route = 6 volunteers
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