Kinetic Time Courses of Bisphenol-S in Volunteers
1 other identifier
interventional
6
1 country
1
Brief Summary
The time course of bisphenol S in plasma and urine will be monitored in female adults exposed to a single oral and dermal dose of bisphenol-S. Six female will be recruited. Blood and urine will be collected at specified times post-treatment. Bisphenol concentrations will be measured in those samples.
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 2018
Typical duration for not_applicable
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
November 7, 2017
CompletedFirst Posted
Study publicly available on registry
November 13, 2017
CompletedStudy Start
First participant enrolled
March 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMay 9, 2018
May 1, 2018
2.8 years
November 7, 2017
May 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Toxicokinetics of bisphenol-S
Time course in blood and urine
0-72 h post-treatment
Study Arms (2)
Bisphenol-S kinetics - oral exposure
EXPERIMENTALSix female volunteers will be exposed orally acute at the reference dose level(0.1 mg / kg bw). For the administration, the product will be dissolved in ethanol (100 mg / ml equivalent to 10 mg / 100 μl) and the solution will be deposited on a cookie (deposit of about 70 μl of solution on a cookie for an individual of 70 kg) and the ethanol is allowed to evaporate before giving each volunteer, with the subsequent consumption of 100 ml of water.
Bisphenol-S kinetics - dermal exposure
EXPERIMENTALvolunteers will be exposed dermally acute at a dose of 1 mg / kg bw. The solution will be applied to an area of 40 cm2 of the forearm and delimited by the indelible marker. The BPS will be added in suspension in an aqueous solution containing 1% of carboxymethylcellulose and administered in the form of drops (70 .mu.l for an individual of 70 kg). The treated area will be left uncoated and unwashed for a period of 4 hours. After 4 hours, the application area will be washed with water and soap. This type of application is therefore similar to an exposure of the general population via the skin (manipulation of cash receipts).
Interventions
Oral and dermal exposure in volunteers
Eligibility Criteria
You may qualify if:
- Female
You may not qualify if:
- People with liver or kidney problems or cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Université de Montréal
Montreal, Quebec, H3C3J7, Canada
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Michèle Bouchard, PhD
Université de Montréal
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full professor
Study Record Dates
First Submitted
November 7, 2017
First Posted
November 13, 2017
Study Start
March 5, 2018
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
May 9, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share