Benzo[a]Pyrene Ultralow Dose-Response Study (NCT03318978) | Clinical Trial Compass
CompletedEarly Phase 1
Benzo[a]Pyrene Ultralow Dose-Response Study
United States8 participantsStarted 2018-04-17
Plain-language summary
Evaluation of the pharmacokinetics for \[14C\]-benzo\[a\]pyrene (\[14C\]-BaP) and metabolites in plasma and urine over 48 hours following 4 oral doses of 25, 50, 10 and 250 ng (2.7-27 nCi).
Who can participate
Age range21 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Inclusion criteria for women:
* Age 21-65 (inclusive)
* Must be post-menopausal or have had surgical sterilization to eliminate any possibility for fetal exposure
* Willing to defer blood donation for one month before, throughout, and one month after completion of study activities
* Willing to avoid consuming cruciferous vegetables, I3C or DIM supplements, smoked or cured meat or cheeses, or charcoal-grilled meats for 2 weeks prior to and during each study cycle (gas grilled foods acceptable)
Inclusion criteria for men:
* Age 21-65 (inclusive)
* Willing to defer blood donation for one month before, throughout, and one month after completion of study activities
* Willing to avoid consuming cruciferous vegetables, I3C or DIM supplements, smoked or cured meat or cheeses, or charcoal-grilled meats for 2 weeks prior to and during each study cycle (gas grilled foods acceptable)
Exclusion Criteria:
Exclusion criteria for both men and women:
* Smoker (tobacco or other substances) or use of smokeless tobacco in past 3 months or living with smoker
* Regular use of medications that affect gut motility or nutrient absorption (e.g. cholestyramine, sucralfate, orlistat, pro- or anti-motility agents)
* History of gastrointestinal surgery (e.g. bariatric surgery, cholecystectomy) or gastrointestinal disorder (Crohn's disease, celiac disease, IBS, or colitis)
* Current or history of kidney or liver disease
* Prior high-dose 14C exposure from medical tests.…
What they're measuring
1
Peak Plasma Concentration Cmax
Timeframe: 0-48 hours for each of the 4 dosing cycles with a washout period of 3 weeks between each dosing cycle