Pharmacokinetic StudyPRECEPTNCT04788810
Toxicokinetic Study of Dichlorobisphenol A After an Oral or Dermal Single Dose in Healthy Volunteer.
A study testing Administration of d12-Cl2BPA in people with Pharmacokinetic Study, run by Poitiers University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 51 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetic Study
- What is being tested?
- Administration of d12-Cl2BPA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2021to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 51 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-51 year old
- No current disease
- BMI range: 18.5-24.9 kg/m²,
- Non smoker
- Normal renal function
- Normal hepatic function
Show all 9Show fewer
- Normal gastrointestinal function
- Affiliated to national health insurance
- Having signed an informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pharmacokinetic Study
- Being tested
- Administration of d12-Cl2BPA
- Keywords
- Toxicokinetics, Endocrine Disruptors, Bisphenol A derivatives
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of d12-Cl2BPAOther
Administration of d12-Cl2BPA
| Study group | Role | What they receive |
|---|---|---|
| Oral route | Experimental | Volunteers receiving d12-Cl2BPA via oral route Receives: Other: Administration of d12-Cl2BPA |
| Dermal route | Experimental | Volunteers receiving d12-Cl2BPA via oral route Receives: Other: Administration of d12-Cl2BPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC)
Non-compartmental and compartmental toxicokinetic analysis
Measured: Hour 0-Hour 24
Cmax
Non-compartmental and compartmental toxicokinetic analysis
Measured: Hour 0-Hour 24
Total clearance
Non-compartmental and compartmental toxicokinetic analysis
Measured: Hour 0 - Hour 24
Volume of distribution
Non-compartmental and compartmental toxicokinetic analysis
Measured: Hour 0 - Hour 24
Secondary outcomes (1)
Secondary toxicokinetic parameters
half-life
Measured: Hour 0 - Hour 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start1 Mar 2021
- Primary completionMar 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pharmacokinetic StudyStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Oral route = 6 volunteers Dermal route = 6 volunteers
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788810
- Sponsor's protocol ID
- 2020-A02116-33
- Acronym
- PRECEPT
- Status last verified
- Mar 2021
- First submitted
- 1 Mar 2021
- Last updated
- 5 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36649713
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toxicokinetic Study of Dichlorobisphenol A After an Oral or Dermal Single Dose in Healthy Volunteer.
- ClinicalTrials.gov ID
- NCT04788810
- Acronym / sponsor ID
- PRECEPT / 2020-A02116-33
- Conditions
- Pharmacokinetic Study
- Keywords
- Toxicokinetics, Endocrine Disruptors, Bisphenol A derivatives
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Oral route = 6 volunteers Dermal route = 6 volunteers
| Arm | Type | Receives |
|---|---|---|
| Oral route | Experimental | Other: Administration of d12-Cl2BPAVolunteers receiving d12-Cl2BPA via oral route |
| Dermal route | Experimental | Other: Administration of d12-Cl2BPAVolunteers receiving d12-Cl2BPA via oral route |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age 18-51 year old
- No current disease
- BMI range: 18.5-24.9 kg/m²,
- Non smoker
- Normal renal function
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of d12-Cl2BPAAdministration of d12-Cl2BPA | Other | Dermal route, Oral route |
Primary outcome
Area under the plasma concentration versus time curve (AUC)
Time frame: Hour 0-Hour 24
Non-compartmental and compartmental toxicokinetic analysis
Cmax
Time frame: Hour 0-Hour 24
Non-compartmental and compartmental toxicokinetic analysis
Total clearance
Time frame: Hour 0 - Hour 24
Non-compartmental and compartmental toxicokinetic analysis
Volume of distribution
Time frame: Hour 0 - Hour 24
Non-compartmental and compartmental toxicokinetic analysis
1 secondary outcome
Secondary toxicokinetic parameters
Time frame: Hour 0 - Hour 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Derived from this study: PubMed 36649713Plattard 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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Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Administration of d12-Cl2BPA in people with Pharmacokinetic Study, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Venisse, PhD, PharmD (+33549444980, nicolas.venisse@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration versus time curve (AUC) (time frame: Hour 0-Hour 24). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04788810, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2021.