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

Pharmacokinetic Study Clinical Trial

— PRECEPT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04788810
• Other study ID #: 2020-A02116-33
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: September 2022

Study information

• Verified date: March 2021
• Source: Poitiers University Hospital
• Contact: Nicolas Venisse, PhD, PharmD
• Phone: +33549444980
• Email: nicolas.venisse[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: September 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 51 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharmacokinetic Study

Intervention

Other:
• Administration of d12-Cl2BPA
Administration of d12-Cl2BPA

Locations

Country	Name	City	State
France	CIC Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration versus time curve (AUC)	Non-compartmental and compartmental toxicokinetic analysis	Hour 0-Hour 24
Primary	Cmax	Non-compartmental and compartmental toxicokinetic analysis	Hour 0-Hour 24
Primary	Total clearance	Non-compartmental and compartmental toxicokinetic analysis	Hour 0 - Hour 24
Primary	Volume of distribution	Non-compartmental and compartmental toxicokinetic analysis	Hour 0 - Hour 24
Secondary	Secondary toxicokinetic parameters	half-life	Hour 0 - Hour 24