Status:
UNKNOWN
Toxicokinetic Study of Dichlorobisphenol A After an Oral or Dermal Single Dose in Healthy Volunteer.
Lead Sponsor:
Poitiers University Hospital
Conditions:
Pharmacokinetic Study
Eligibility:
FEMALE
18-51 years
Phase:
NA
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 incl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04788810
Start Date
March 1 2021
End Date
September 1 2022
Last Update
April 5 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CIC Poitiers
Poitiers, France