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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propylene glycol-containing beverage | Experimental | Participants will consume a beverage containing propylene glycol (PG) with standardized meals at Visits 2, 4, and 6. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum PG Levels | The difference in baseline serum PG levels between each study period. | Baseline (pre-dose) at each dosing visit |
| Tmax | Assessment of Tmax for PG following consumption of one, two, or three PG containing beverages. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically relevant changes in blood pressure after supplementation | Clinically relevant changes in blood pressure (mmHg) following consumption of PG-containing beverages. | From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12) |
| Clinically relevant changes in aspartate aminotransferase |
Inclusion Criteria:
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
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)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erin Lewis, PhD | Contact | 1-226-242-4551 | 248 | elewis@kgkscience.com |
| Name | Affiliation | Role |
|---|---|---|
| David Crowley | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Science Inc. | Recruiting | London | Ontario | N5Y 5V6 | Canada |
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Upon request (with justification provided), as agreed to by the sponsor. The confidentiality of the participants must be preserved and blinded.
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| ID | Term |
|---|---|
| D019946 | Propylene Glycol |
| ID | Term |
|---|---|
| D011409 | Propylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| 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. | From pre-dose through 24 hours post-dose |
| AUC0-∞ | Assessment of AUC0-∞ for PG following consumption of one, two, or three PG containing beverages. | 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. | 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. | 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. | 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. | 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. | 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 |
Clinically relevant changes in aspartate aminotransferase (U/L) following consumption of PG-containing beverages. |
| From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12) |
| Clinically relevant changes in red blood cell count | Clinically relevant changes in red blood cell count (x 10^12/L) following consumption of PG-containing beverages. | From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12) |
| Clinically relevant changes in heart rate after supplementation | Clinically relevant changes in heart rate (beats per minute) following consumption of PG-containing beverages. | From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12) |
| Clinically relevant changes in body temperature after supplementation | Clinically relevant changes in body temperature (°C) following consumption of PG-containing beverages. | From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12) |
| Clinically relevant changes in oxygen levels after supplementation | Clinically relevant changes in oxygen levels (%) following consumption of PG-containing beverages. | From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12) |
| Clinically relevant changes in alanine aminotransferase | Clinically relevant changes in alanine aminotransferase (U/L) following consumption of PG-containing beverages. | From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12) |
| Clinically relevant changes in alkaline phosphatase | Clinically relevant changes in alkaline phosphatase (U/L) following consumption of PG-containing beverages. | From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12) |
| Clinically relevant changes in total bilirubin | Clinically relevant changes in total bilirubin (micromole/litre) following consumption of PG-containing beverages. | From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12) |
| Clinically relevant changes in creatinine | Clinically relevant changes in creatinine (micromole/litre) following consumption of PG-containing beverages. | From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12) |
| Clinically relevant changes in sodium | Clinically relevant changes in sodium (mmol/L) following consumption of PG-containing beverages. | From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12) |
| Clinically relevant changes in potassium | Clinically relevant changes in potassium (mmol/L) following consumption of PG-containing beverages. | From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12) |
| Clinically relevant changes in chloride | Clinically relevant changes in chloride (mmol/L) following consumption of PG-containing beverages. | From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12) |
| Clinically relevant changes in estimated glomerular filtration rate | Clinically relevant changes in estimated glomerular filtration rate (mL/min/1.73 m^2) following consumption of PG-containing beverages. | From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12) |
| Clinically relevant changes in glucose | Clinically relevant changes in glucose (mmol/L) following consumption of PG-containing beverages. | From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12) |
| Clinically relevant changes in white blood cell count | Clinically relevant changes in white blood cell (x 10^9/L) count following consumption of PG-containing beverages. | From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12) |
| Clinically relevant changes in platelet count | Clinically relevant changes in platelet count (x10^9/L) following consumption of PG-containing beverages. | From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12) |
| Clinically relevant changes in hemoglobin | Clinically relevant changes in hemoglobin (g/L) following consumption of PG-containing beverages. | From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12) |
| Clinically relevant changes in hematocrit | Clinically relevant changes in hematocrit (L/L) following consumption of PG-containing beverages. | From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12) |
| Clinically relevant changes in red blood cell indices (MCV) | Clinically relevant changes in MCV (fL) following consumption of PG-containing beverages. | From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12) |
| Clinically relevant changes in red blood cell indices (MCH) | Clinically relevant changes in MCH (pg) following consumption of PG-containing beverages. | From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12) |
| Clinically relevant changes in red blood cell indices (MCHC) | Clinically relevant changes in MCHC (g/L) following consumption of PG-containing beverages. | From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12) |
| Clinically relevant changes in RDW | Clinically relevant changes in RDW (%) following consumption of PG-containing beverages. | From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12) |
| Clinically relevant changes in red blood cell indices (MPV) | Clinically relevant changes in MPV (fL) following consumption of PG-containing beverages. | From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12) |