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

March 31, 2021 updated by: Poitiers University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Poitiers, France
        • Recruiting
        • CIC Poitiers
        • Contact:
          • PJ SAULNIER, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 51 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral route
Volunteers receiving d12-Cl2BPA via oral route
Other: Administration of d12-Cl2BPA
Administration of d12-Cl2BPA
Experimental: Dermal route
Volunteers receiving d12-Cl2BPA via oral route
Other: Administration of d12-Cl2BPA
Administration of d12-Cl2BPA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the plasma concentration versus time curve (AUC)
Time Frame: Hour 0-Hour 24
Non-compartmental and compartmental toxicokinetic analysis
Hour 0-Hour 24
Cmax
Time Frame: Hour 0-Hour 24
Non-compartmental and compartmental toxicokinetic analysis
Hour 0-Hour 24
Total clearance
Time Frame: Hour 0 - Hour 24
Non-compartmental and compartmental toxicokinetic analysis
Hour 0 - Hour 24
Volume of distribution
Time Frame: Hour 0 - Hour 24
Non-compartmental and compartmental toxicokinetic analysis
Hour 0 - Hour 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary toxicokinetic parameters
Time Frame: Hour 0 - Hour 24
half-life
Hour 0 - Hour 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

March 1, 2021

First Submitted That Met QC Criteria

March 5, 2021

First Posted (Actual)

March 9, 2021

Study Record Updates

Last Update Posted (Actual)

April 5, 2021

Last Update Submitted That Met QC Criteria

March 31, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020-A02116-33

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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