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

NCT07644169 | Not Yet Recruiting

• 1 other identifier: 26ABAKC01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

propylene glycol

Outcome Measures

Primary Outcomes (1)

• The maximum concentration of propylene glycol in serum

  The maximum concentration (Cmax) of propylene glycol (PG) in serum following consumption of one, two, or three PG-containing beverages.

  From pre-dose through 24 hours post-dose.

Secondary Outcomes (9)

• Serum PG Levels

  Baseline (pre-dose) at each dosing visit

• Tmax

  From pre-dose through 24 hours post-dose

• Area Under the Curve (AUC0-24hrs)

  From pre-dose through 24 hours post-dose

• AUC0-∞

  From pre-dose through 24 hours post-dose

• Terminal elimination half-life (t1/2)

  From pre-dose through 24 hours post-dose

Other Outcomes (24)

• Clinically relevant changes in blood pressure after supplementation

  From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12)

• Clinically relevant changes in aspartate aminotransferase

  From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12)

• Clinically relevant changes in red blood cell count

  From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12)

Study Arms (1)

Propylene glycol-containing beverage

EXPERIMENTAL

Participants will consume a beverage containing propylene glycol (PG) with standardized meals at Visits 2, 4, and 6.

Other: Propylene glycol

Interventions

Propylene glycol OTHER

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.

Propylene glycol-containing beverage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females 18 years and older
• Body Mass Index (BMI) between 18.5 to 29.9 kg/m2
• Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,
• Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
• Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Nexplanon)
• Double-barrier method
• Intrauterine devices
• Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
• Vasectomy of partner at least 6 months prior to screening
• Abstinence and agrees to use contraception if planning on becoming sexually active during the study
• Agrees to refrain from vigorous physical activity and alcohol consumption 24 hours prior to dosing day (i.e., Day 1 of each study period which corresponds to Visits 2, 4, 6) and Day 2 of each study period
• Willingness to complete diaries, food records, and to complete all clinic visits
• Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study
• Provided voluntary, written, informed consent to participate in the study
• Healthy as determined by medical history and laboratory results as assessed by the Qualified Investigator (QI)

You may not qualify if:

• Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
• Allergy, sensitivity, or intolerance, preventing consumption of investigational product ingredients and standardized meal
• Individuals with alcohol dehydrogenase deficiency as assessed by the QI
• Poor venous access as assessed by the QI
• History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
• Significant cardiovascular event in the past 6 months. (Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis.)
• Self-reported confirmation of any significant neuropsychological condition (e.g., Schizophrenia, bipolar disorder, post-traumatic stress disorder, brain injury, neurodegenerative disease, infections, insomnia, anxiety, depression, epileptic or other seizure-related disorders) as assessed by the QI
• Unstable metabolic disease or chronic diseases as assessed by the QI
• Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
• Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3)
• Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
• Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. (Participants with minor surgery will be considered on a case-by-case basis by the QI.)
• Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable.
• Individuals with an autoimmune disease or are immune compromised as assessed by the QI.
• Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI

Sponsors & Collaborators

• American Beverage Association: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N5Y 5V6, Canada

Location

MeSH Terms

Interventions

Propylene Glycol

Intervention Hierarchy (Ancestors)

Propylene Glycols; Glycols; Alcohols; Organic Chemicals

Study Officials

• David Crowley

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Lewis, PhD

CONTACT

1-226-242-4551; elewis@kgkscience.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 12, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Access Criteria: Upon request (with justification provided), as agreed to by the sponsor. The confidentiality of the participants must be preserved and blinded.

Locations

CA (1)