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A Clinical Trial to Assess the Pharmacokinetic Profile of Propylene Glycol (PG) in Healthy Adults Following PG Exposure

NCT07644169 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-08

No results posted yet for this study

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

Conditions

  • Healthy
  • Pharmacokinetic Profile
  • Propylene Glycol

Interventions

OTHER

Propylene glycol

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.

Sponsors & Collaborators

  • KGK Science Inc.

    collaborator INDUSTRY

  • American Beverage Association

    lead OTHER

Principal Investigators

  • David Crowley · KGK Science Inc.

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-02
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07644169 on ClinicalTrials.gov