Healthy VolunteersPhase 1NCT01573429
Bisphenol A Controlled Exposure Study
A Phase 1 study testing deuterated-Bisphenol A (d-BPA) in people with Healthy Volunteers, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial summary
Background: Bisphenol A (BPA) is a chemical that is used primarily to make plastics, resins, and thermal paper. Most people are exposed daily to low levels of BPA that leaches into food and water from plastic products, including water and baby bottles. However, not all of the risks of BPA are known. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- deuterated-Bisphenol A (d-BPA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2012to 16 Jun 2020
- Phase
- Phase 1
- 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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants meeting all of the following criteria will be considered for admission into this study:
- Male or female 25-45 years of age at the time of enrollment.
- Able to fast overnight (at least 8 hours).
- Able to understand and provide written informed consent in English.
- Able to travel to the NIEHS Clinical Research Unit (CRU) for all required study visits.
- Male and females of reproductive age agree to use contraception to avoid conceiving a child and agree not to donate eggs or sperm for six months following their participation in the study.
Who cannot join
- Uncontrolled diabetes:
- --Hemoglobin A1C of greater than or equal to 6.5% or a fasting blood glucose of greater than or equal to 126 mg/dL.
- Known liver dysfunction or disease:
- ALT - higher than the normative value or determined abnormal by the PI.
- AST - higher than the normative value or determined abnormal by the PI.
- ALP - higher than the normative value or determined abnormal by the PI.
Show all 14Show fewer
- Known kidney dysfunction or disease:
- Estimated Glomerular Filtration Rate (eGFR)- <60 ml/min per the MDRD equation.
- Clinically relevant anemia as defined as hemoglobin concentration <13g/dL for males and hemoglobin concentration <11g/dL for females.
- Pregnancy: Positive serum quantitative hCG pregnancy test.
- Current lactation.
- BMI less than or equal to 19 and greater than or equal to 35
- Medication use: Given the widespread use of medications, it may not be practical to instruct subjects to avoid all medication prior to and during the study. Thus, participant exclusion will be based on use of medications within 48 hours of the exposure and for the 6 days following the exposure that affect glucuronidation of the d-BPA dosage: Salicylic acid, acetaminophen, ibuprofen, naproxen, mefenamic acid, diclofenac, gliclazide carbamazepine, valproic acid, cimetidine, sulfasalazine, amoxicillin and erythromycin.
- Recent blood donation within the past 8 weeks of the BPA exposure visit (so as not to exceed donation of 10.5 mL/kg or 550 mL over an 8 week period).
Trial locations and contacts
1 site in 1 country.
United States1 site
NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina
About this study
Official title: Bisphenol A (BPA) Pharmacokinetic (PK): Controlled Exposure Study
Background:
- Bisphenol A (BPA) is a chemical that is used primarily to make plastics, resins, and thermal paper. Most people are exposed daily to low levels of BPA that leaches into food and water from plastic products, including water and baby bottles. However, not all of the risks of BPA are known. Researchers want to learn more about how BPA acts in the body, and how the body gets rid of BPA.
Read more
Objectives:
- To study controlled exposure to BPA and its effects on the body.
Eligibility:
- Healthy, non-obese volunteers between 25 and 45 years of age.
Design:
- Participants will have six visits over about 2 to 4 weeks for this study.
- At the first visit, participants will be screened with a physical exam and blood and urine tests. They will complete a questionnaire about exposure to BPA-containing products. They will also receive a list of medications that should not be taken during the study period.
- The second visit will last about 13 hours. Participants will fast for 8 hours before the visit. They will then have a single dose of d-BPA (a modified form of BPA that is easier to study in the body). Regular blood samples will be taken over the 13-hour visit. All urine will also be collected. Participants will receive breakfast and lunch during the visit.
- Participants will have four follow-up visits. They will collect and store all of their urine between each follow-up visit. Blood samples will be collected at the follow-up visits....
Read the detailed description
Bisphenol A (BPA) is utilized primarily in the manufacture of polycarbonate plastic and epoxy resins, which are widely used in the fabrication of baby bottles and food can linings. Consequently, human exposures to BPA are widespread. However, there is still uncertainty about the extent and nature of these exposures. This pharmacokinetic (PK) study is aimed at refining our understanding of the metabolism and excretion of BPA following two different routes of administration. This investigation is also intended to help resolve current controversies in BPA risk assessment. We will administer 100 microgram/kg body weight (bw) of deuterated BPA (d-BPA) orally and/or dermally (as an ethanol solution or a carboxymethylcellulose suspension), in up to 50 participants, with comparable numbers of men to women, and collect blood and urine for measurements of d-BPA and d-BPA conjugates at selected time points over a six day period post-dosing. The use of d-BPA will allow the detection of the administered BPA to be distinguished from background BPA. The primary endpoint of the study is detection of measurable d-BPA and d-BPA conjugates in blood and urine after administration of a single dose of 100 microgram/kg bw d-BPA applied orally and/or dermally (as an ethanol solution or a carboxymethylcellulose suspension). Participants will be given an option to complete either one or both phases of the study, the exposure visits separated by a period of at least 4 weeks. Dose selection was based on balancing the need for detectable levels of BPA in blood and urine to meet the objective and the need to minimize human subject risk. Data from the first 3 participants in the study, who received oral d-BPA, confirmed dosing during the oral pilot phase was sufficient in capturing measurable d-BPA in blood and urine and will continue at 100 microgram/kg bw of d-BPA for oral dosing. Dermal exposure will consist of a pilot phase for this route of administration comprising 4 participants to assess whether 100 microgram/kg bw of d-BPA applied to the skin is sufficient to obtain measurable d-BPA in blood and/or urine in order to establish PK parameters and to evaluate whether the time points are appropriate and necessary. If needed, the dermal pilot phase will be repeated using an ethanol solution rather than a carboxymethylcellulose suspension. The design includes sufficient sampling of blood and urine to define relevant PK parameters, including the rate of BPA absorption, plasma elimination rate, area under the curve (AUC) and apparent clearance, half-life, the urinary excretion rate, and the fractional metabolic clearance of the glucuronide and sulfate conjugates.
- Conditions
- Healthy Volunteers
- Being tested
- deuterated-Bisphenol A (d-BPA)
- Keywords
- Biologic Sample Collection, Metabolism, Healthy Volunteer, HV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deuterated-Bisphenol A (d-BPA)Other
The primary endpoints are key pharmacokinetic measurements of d-BPA and d-BPA conjugates in blood and urine over 6 days after a single dose of oral and/or ethanol solution dermal application and/or a carboxymethylcellulose suspension dermal application of a dose of 100 micro g/kg bw of d-BPA.
| Study group | Role | What they receive |
|---|---|---|
| Dermal Carboxymethylcellulose arm | Other | d-BPA administered dermally using a carboxymethylcellulose suspension Receives: Other: deuterated-Bisphenol A (d-BPA) |
| Dermal ethanol arm | Other | d-BPA is administered dermally using an ethanol solution Receives: Other: deuterated-Bisphenol A (d-BPA) |
| Oral arm | Other | d-BPA administered orally Receives: Other: deuterated-Bisphenol A (d-BPA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of d-BPA and d-BPA conjugates in blood and urine over 6 days
The primary endpoints are key pharmacokinetic measurements of d-BPA and d-BPA conjugates in blood and urine over 6 days after a single dose of oral and/or ethanol solution dermal application and/or acarboxymethylcellulose suspension dermal application of a dose of 100 micro g/kg bw of d-BPA.
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2012 (estimated)
- Study start18 Jul 2012
- Primary completion16 Jun 2020
- Study completion16 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Stavros Garantziotis, M.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01573429
- Sponsor's protocol ID
- 120089
- Other IDs
- 12-E-0089
- Status last verified
- Nov 2021
- First submitted
- 4 Apr 2012
- Last updated
- 18 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bisphenol A (BPA) Pharmacokinetic (PK): Controlled Exposure Study
- ClinicalTrials.gov ID
- NCT01573429
- Acronym / sponsor ID
- 120089
- Conditions
- Healthy Volunteers
- Keywords
- Biologic Sample Collection, Metabolism, Healthy Volunteer, HV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 18 Jul 2012 (actual)
- Primary completion
- 16 Jun 2020 (actual)
- Study completion
- 16 Jun 2020 (actual)
- First posted
- 9 Apr 2012 (estimated)
- 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.
Background:
- Bisphenol A (BPA) is a chemical that is used primarily to make plastics, resins, and thermal paper. Most people are exposed daily to low levels of BPA that leaches into food and water from plastic products, including water and baby bottles. However, not all of the risks of BPA are known. Researchers want to learn more about how BPA acts in the body, and how the body gets rid of BPA.
Objectives:
- To study controlled exposure to BPA and its effects on the body.
Eligibility:
- Healthy, non-obese volunteers between 25 and 45 years of age.
Design:
- Participants will have six visits over about 2 to 4 weeks for this study.
- At the first visit, participants will be screened with a physical exam and blood and urine tests. They will complete a questionnaire about exposure to BPA-containing products. They will also receive a list of medications that should not be taken during the study period.
- The second visit will last about 13 hours. Participants will fast for 8 hours before the visit. They will then have a single dose of d-BPA (a modified form of BPA that is easier to study in the body). Regular blood samples will be taken over the 13-hour visit. All urine will also be collected. Participants will receive breakfast and lunch during the visit.
- Participants will have four follow-up visits. They will collect and store all of their urine between each follow-up visit. Blood samples will be collected at the follow-up visits....
Detailed description
Bisphenol A (BPA) is utilized primarily in the manufacture of polycarbonate plastic and epoxy resins, which are widely used in the fabrication of baby bottles and food can linings. Consequently, human exposures to BPA are widespread. However, there is still uncertainty about the extent and nature of these exposures. This pharmacokinetic (PK) study is aimed at refining our understanding of the metabolism and excretion of BPA following two different routes of administration. This investigation is also intended to help resolve current controversies in BPA risk assessment. We will administer 100 microgram/kg body weight (bw) of deuterated BPA (d-BPA) orally and/or dermally (as an ethanol solution or a carboxymethylcellulose suspension), in up to 50 participants, with comparable numbers of men to women, and collect blood and urine for measurements of d-BPA and d-BPA conjugates at selected time points over a six day period post-dosing. The use of d-BPA will allow the detection of the administered BPA to be distinguished from background BPA. The primary endpoint of the study is detection of measurable d-BPA and d-BPA conjugates in blood and urine after administration of a single dose of 100 microgram/kg bw d-BPA applied orally and/or dermally (as an ethanol solution or a carboxymethylcellulose suspension). Participants will be given an option to complete either one or both phases of the study, the exposure visits separated by a period of at least 4 weeks. Dose selection was based on balancing the need for detectable levels of BPA in blood and urine to meet the objective and the need to minimize human subject risk. Data from the first 3 participants in the study, who received oral d-BPA, confirmed dosing during the oral pilot phase was sufficient in capturing measurable d-BPA in blood and urine and will continue at 100 microgram/kg bw of d-BPA for oral dosing. Dermal exposure will consist of a pilot phase for this route of administration comprising 4 participants to assess whether 100 microgram/kg bw of d-BPA applied to the skin is sufficient to obtain measurable d-BPA in blood and/or urine in order to establish PK parameters and to evaluate whether the time points are appropriate and necessary. If needed, the dermal pilot phase will be repeated using an ethanol solution rather than a carboxymethylcellulose suspension. The design includes sufficient sampling of blood and urine to define relevant PK parameters, including the rate of BPA absorption, plasma elimination rate, area under the curve (AUC) and apparent clearance, half-life, the urinary excretion rate, and the fractional metabolic clearance of the glucuronide and sulfate conjugates.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dermal Carboxymethylcellulose arm | Other | Other: deuterated-Bisphenol A (d-BPA)d-BPA administered dermally using a carboxymethylcellulose suspension |
| Dermal ethanol arm | Other | Other: deuterated-Bisphenol A (d-BPA)d-BPA is administered dermally using an ethanol solution |
| Oral arm | Other | Other: deuterated-Bisphenol A (d-BPA)d-BPA administered orally |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants meeting all of the following criteria will be considered for admission into this study:
- Male or female 25-45 years of age at the time of enrollment.
- Able to fast overnight (at least 8 hours).
- Able to understand and provide written informed consent in English.
- Able to travel to the NIEHS Clinical Research Unit (CRU) for all required study visits.
Key exclusion criteria (14 listed)
- Uncontrolled diabetes:
- --Hemoglobin A1C of greater than or equal to 6.5% or a fasting blood glucose of greater than or equal to 126 mg/dL.
- Known liver dysfunction or disease:
- Known kidney dysfunction or disease:
- Pregnancy: Positive serum quantitative hCG pregnancy test.
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 |
|---|---|---|
| deuterated-Bisphenol A (d-BPA)The primary endpoints are key pharmacokinetic measurements of d-BPA and d-BPA conjugates in blood and urine over 6 days after a single dose of oral and/or ethanol solution dermal application and/or a carboxymethylcellulose suspension dermal application of a dose of 100 micro g/kg bw of d-BPA. | Other | Dermal Carboxymethylcellulose arm, Dermal ethanol arm, Oral arm |
Primary outcome
Pharmacokinetics of d-BPA and d-BPA conjugates in blood and urine over 6 days
Time frame: 6 days
The primary endpoints are key pharmacokinetic measurements of d-BPA and d-BPA conjugates in blood and urine over 6 days after a single dose of oral and/or ethanol solution dermal application and/or acarboxymethylcellulose suspension dermal application of a dose of 100 micro g/kg bw of d-BPA.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Stavros Garantziotis, M.D. principal investigator
National Institute of Environmental Health Sciences (NIEHS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing deuterated-Bisphenol A (d-BPA) in people with Healthy Volunteers, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
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 6 inclusion and 14 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: finished, as of the sponsor's last update on 18 Nov 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics of d-BPA and d-BPA conjugates in blood and urine over 6 days (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2021.