Bisphenol A Controlled Exposure Study

NCT01573429 | Completed Phase 1

• 2 other identifiers: 12008912-E-0089
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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. 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....

Conditions

Healthy Volunteers

Keywords

Biologic Sample Collection; Metabolism; Healthy Volunteer; HV

Outcome Measures

Primary Outcomes (1)

• 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.

  6 days

Study Arms (3)

Dermal Carboxymethylcellulose arm

OTHER

d-BPA administered dermally using a carboxymethylcellulose suspension

Other: deuterated-Bisphenol A (d-BPA)

Dermal ethanol arm

OTHER

d-BPA is administered dermally using an ethanol solution

Other: deuterated-Bisphenol A (d-BPA)

Oral arm

OTHER

d-BPA administered orally

Other: deuterated-Bisphenol A (d-BPA)

Interventions

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.

Dermal Carboxymethylcellulose arm; Dermal ethanol arm; Oral arm

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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
• 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).

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (1)

NIEHS Clinical Research Unit (CRU)

Research Triangle Park, North Carolina, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Stavros Garantziotis, M.D.

  National Institute of Environmental Health Sciences (NIEHS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2012
• First Posted: April 9, 2012
• Study Start: July 18, 2012
• Primary Completion: June 16, 2020
• Study Completion: June 16, 2020
• Last Updated: November 18, 2021

Record last verified: 2021-11

Locations

US (1)