At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Dose-escalation Clinical Trial to Assess the Pharmacokinetic Profile of Propylene Glycol (PG) in Healthy Adults Following PG Exposure
In Brief
A clinical study evaluating Propylene glycol for Healthy and 2 related conditions. Not yet recruiting, targeting 30 participants across 1 site.
Detailed Summary
The goal of this clinical trial is to determine the translation of propylene glycol (PG) exposure in beverages to circulating PG levels to better understand the margin of safety in healthy participants. The main question it aims to answer is what is the maximum concentration (Cmax) of propylene glycol (PG) in serum following consumption of one, two, or three PG-containing beverages? Participants will be asked to: * Consume 1x, 2x, and 3x 12oz of PG-containing beverage * Have their blood drawn * Complete urine pregnancy testing if of childbearing potential * Complete a study diary and record their food and beverage consumption * Have their vital signs and oxygen measurements taken
Study Details
Timeline
Interventions
At Visits 2, 4, and 6, participants will consume 1X, 2X, and 3X 12 oz of a PG-containing beverage (in bottle format) with standardized meals in the presence of the study staff over the course of the dosing day. Participants will consume the beverage and standardized meal within 15 minutes. The only beverage allowed during the visit - other than the intent-to-treat beverage - will be water.