HealthyNCT07644169
A Clinical Trial to Assess the Pharmacokinetic Profile of Propylene Glycol (PG) in Healthy Adults Following PG Exposure
A study testing Propylene glycol in people with Healthy and Pharmacokinetic Profile, run by American Beverage Association at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Pharmacokinetic Profile, Propylene Glycol
- What is being tested?
- Propylene glycol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 9 Jul 2026to 3 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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.)
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- 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
- Self-reported confirmation of blood/bleeding disorders as assessed by the QI
- Use of prescribed cannabinoid products
- Chronic use of cannabinoid products (>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period
- Regular use of e-cigarettes, tobacco or nicotine products in the past six months, as assessed by the QI. Occasional users will be required to washout (1 month) and abstain for the duration of the study period.
- Alcohol intake average of >1 standard drinks per day as assessed by the QI
- Alcohol or drug abuse within the last 12 months
- Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the safety of the investigational product (Sections 7.3.1 and 7.3.2)
- Clinically significant abnormal laboratory results at screening as assessed by the QI
- Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
- Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
- Individuals who are unable to give informed consent
- Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Dose-escalation Clinical Trial to Assess the Pharmacokinetic Profile of Propylene Glycol (PG) in Healthy Adults Following PG Exposure
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
- Being tested
- Propylene glycol
- Keywords
- propylene glycol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propylene glycolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Propylene glycol-containing beverage | Experimental | Participants will consume a beverage containing propylene glycol (PG) with standardized meals at Visits 2, 4, and 6. Receives: Other: Propylene glycol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From pre-dose through 24 hours post-dose.
Secondary outcomes (9)
Serum PG Levels
The difference in baseline serum PG levels between each study period.
Measured: Baseline (pre-dose) at each dosing visit
Tmax
Assessment of Tmax for PG following consumption of one, two, or three PG containing beverages.
Measured: From pre-dose through 24 hours post-dose
Area Under the Curve (AUC0-24hrs)
Assessment of Area Under the Curve (AUC0-24hrs) for PG following consumption of one, two, or three PG containing beverages.
Measured: From pre-dose through 24 hours post-dose
AUC0-∞
Assessment of AUC0-∞ for PG following consumption of one, two, or three PG containing beverages.
Measured: From pre-dose through 24 hours post-dose
Terminal elimination half-life (t1/2)
Assessment of terminal elimination half-life (t1/2) for PG following consumption of one, two, or three PG containing beverages.
Measured: From pre-dose through 24 hours post-dose
Measured and calculated osmolality
Analysis of osmolality at baseline (0 hour) and at each timepoint (0.5 hour, 1 hour, 1.5 hours, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 9 hours, 12 hours, 24 hours) following consumption of one, two, or three PG containing beverages. Calculated osmolality will be derived from serum sodium, urea, and glucose concentrations.
Measured: Assessed at baseline (0 hour) and at 0.5 hour, 1 hour, 1.5 hours, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 9 hours, 12 hours, and 24 hours post-dose
Blood osmolal gap
Analysis of blood osmolal gap at baseline (0 hour) and at each timepoint (0.5 hour, 1 hour, 1.5 hours, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 9 hours, 12 hours, 24 hours) following consumption of one, two, or three PG containing beverages.
Measured: Assessed at baseline (0 hour) and at 0.5 hour, 1 hour, 1.5 hours, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 9 hours, 12 hours, and 24 hours post-dose
Serum lactate concentration
Analysis of serum lactate concentrations at baseline (0 hour) and at each timepoint (0.5 hour, 1 hour, 1.5 hours, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 9 hours, 12 hours, 24 hours) following consumption of one, two, or three PG containing beverages.
Measured: Assessed at baseline (0 hour) and at 0.5 hour, 1 hour, 1.5 hours, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 9 hours, 12 hours, and 24 hours post-dose
pyruvate concentration
Analysis of pyruvate concentrations at baseline (0 hour) and at each timepoint (0.5 hour, 1 hour, 1.5 hours, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 9 hours, 12 hours, 24 hours) following consumption of one, two, or three PG containing beverages.
Measured: Assessed at baseline (0 hour) and at 0.5 hour, 1 hour, 1.5 hours, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 9 hours, 12 hours, and 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start9 Jul 2026
- Primary completion3 Sep 2026
- Study completion3 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Beverage Association
- Sponsor type
- University, hospital or other
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644169
- Sponsor's protocol ID
- 26ABAKC01
- Status last verified
- Sep 2026
- First submitted
- 4 Jun 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Dose-escalation Clinical Trial to Assess the Pharmacokinetic Profile of Propylene Glycol (PG) in Healthy Adults Following PG Exposure
- ClinicalTrials.gov ID
- NCT07644169
- Acronym / sponsor ID
- 26ABAKC01
- Conditions
- Healthy, Pharmacokinetic Profile, Propylene Glycol
- Keywords
- propylene glycol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- American Beverage AssociationUniversity, hospital or other
- Collaborators
- KGK Science Inc.
- Study start
- 9 Jul 2026 (actual)
- Primary completion
- 3 Sep 2026 (actual)
- Study completion
- 3 Sep 2026 (actual)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Propylene glycol-containing beverage | Experimental | Other: Propylene glycolParticipants will consume a beverage containing propylene glycol (PG) with standardized meals at Visits 2, 4, and 6. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- 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
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propylene glycolAt 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. | Other | Propylene glycol-containing beverage |
Primary outcome
The maximum concentration of propylene glycol in serum
Time frame: From pre-dose through 24 hours post-dose.
The maximum concentration (Cmax) of propylene glycol (PG) in serum following consumption of one, two, or three PG-containing beverages.
9 secondary outcomes
Serum PG Levels
Time frame: Baseline (pre-dose) at each dosing visit
Tmax
Time frame: From pre-dose through 24 hours post-dose
Area Under the Curve (AUC0-24hrs)
Time frame: From pre-dose through 24 hours post-dose
AUC0-∞
Time frame: From pre-dose through 24 hours post-dose
Terminal elimination half-life (t1/2)
Time frame: From pre-dose through 24 hours post-dose
Measured and calculated osmolality
Time frame: Assessed at baseline (0 hour) and at 0.5 hour, 1 hour, 1.5 hours, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 9 hours, 12 hours, and 24 hours post-dose
Blood osmolal gap
Time frame: Assessed at baseline (0 hour) and at 0.5 hour, 1 hour, 1.5 hours, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 9 hours, 12 hours, and 24 hours post-dose
Serum lactate concentration
Time frame: Assessed at baseline (0 hour) and at 0.5 hour, 1 hour, 1.5 hours, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 9 hours, 12 hours, and 24 hours post-dose
pyruvate concentration
Time frame: Assessed at baseline (0 hour) and at 0.5 hour, 1 hour, 1.5 hours, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 9 hours, 12 hours, and 24 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Crowley principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propylene glycol in people with Healthy and Pharmacokinetic Profile, run by American Beverage Association at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximum concentration of propylene glycol in serum (time frame: From pre-dose through 24 hours post-dose.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.