Toxicokinetic Study of Dichlorobisphenol A After an Oral or Dermal Single Dose in Healthy Volunteer.
PRECEPT
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2021
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedFirst Posted
Study publicly available on registry
March 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedApril 5, 2021
March 1, 2021
1 year
March 1, 2021
March 31, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Secondary Outcomes (1)
Secondary toxicokinetic parameters
Hour 0 - Hour 24
Study Arms (2)
Oral route
EXPERIMENTALVolunteers receiving d12-Cl2BPA via oral route
Dermal route
EXPERIMENTALVolunteers receiving d12-Cl2BPA via oral route
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CIC Poitiers
Poitiers, France
Related Publications (1)
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.
PMID: 36649713DERIVED
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2021
First Posted
March 9, 2021
Study Start
March 1, 2021
Primary Completion
March 1, 2022
Study Completion
September 1, 2022
Last Updated
April 5, 2021
Record last verified: 2021-03