Sources of Exposure to Plastic-Associated Chemicals (PAC) in People living in the Perth Region.

Not Applicable

• Conditions: Endocrine disruption; Inflammation; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12622001259730
• Lead Sponsor: The University of Western Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-20
• Last Update Posted: 26 September 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Healthy biological males or healthy, non-pregnant, non-lactating biological females aged 18 to 60 years.
2. Body mass index between greater than or equal to 18.5 and less than or equal to 34.9 kg/m2. If outside this range, eligible at investigator’s discretion.
3. Currently healthy (mentally and physically) in the opinion of the investigator based on a comprehensive clinical assessment (detailed medical history and physical examination), electrocardiogram (ECG), vital signs, and laboratory investigations (hematology, clinical chemistry, coagulation, and urinalysis).
4. Lives in the Perth Metropolitan Area.
5. Ability to give written informed consent.

Exclusion Criteria

1. History of drug or alcohol abuse in the past 24 months. Alcohol abuse defined as less than 21 units/week for males, and greater than 14/units for females.
2. Current regular smoker or e-cigarette use. Social smokers (less than 3 nicotine/tobacco products in the last 3 months) can be included if abstaining for the duration of the study.
3. Currently pregnant or planning pregnancy during the course of the study as assessed by pregnancy testing carried out during screening.
4. Not suitable for the study for any other reason, as determined by the investigator.
5. Acute infection, surgery, vaccination, or other inflammatory process in the previous 2 weeks. Minor procedures are exempt at investigator’s discretion.
6. Evidence of moderate or greater renal impairment at screening, as indicated by an estimated creatinine clearance of less than 60 mL/min using the Cockcroft-Gault equation.
7. Clinically significant abnormal laboratory tests, as determined by the investigator, not otherwise mentioned.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of metabolites of plastic-associated chemicals (PAC) determined by urine analysis, from at least one of the two Time Points 2 and 4, reported for N=200 participants recruited. [Within four months after the last participant is enrolled in the trial. ]