Clinical trial NCT06345950: Pharmacokinetics and Safety of a New Micellar Glutathione Formulation
Official title: Pharmacokinetics and Safety of a New Micellar Glutathione Formulation in Human Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bioavailability
Safety
Keywords: pharmacokinetics
glutathione
bioavailability
safety
micellar delivery system
Lead sponsor: Factors Group of Nutritional Companies Inc.
Sponsor class: INDUSTRY
Collaborators: name: Isura
First posted: 2024-04-03
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants are randomly assigned to interventions in a crossover design to assess the pharmacokinetics over 24 hours; subsequently, the safety of one intervention with higher bioavailability is evaluated in an additional single-arm, 30-day trial.
Primary purpose: TREATMENT

Brief summary: This study seeks to determine the short-term effects of daily oral supplementation with a new micellar Glutathione formulation (LipoMicel) on the oral absorption and safety of glutathione in healthy volunteers.

The primary objective of this study is to evaluate and compare the pharmacokinetics of a novel micellar Glutathione (GSH) formulation with that of a standard formulation as well as a liposomal GSH formulation. The secondary objective is to evaluate the safety of a new micellar GSH formulation with higher bioavailability in human participants over a 30-day study period.


Eligibility criteria: Inclusion Criteria:

* male or female aged 21-65 years
* healthy, good physical condition
* voluntary, written, informed consent to participate in the study.

Exclusion Criteria:

* use of anti-inflammatory or non-steroidal anti-inflammatory drugs
* previous history of cardiovascular disease or acute or chronic inflammatory disease
* use of antioxidant supplements or cholesterol-lowering agents
* change of diet habits or lifestyle (diet, physical activity, etc.)
* alcohol or substance abuse history
* use of nicotine or tobacco
* participation in another investigational study

Primary outcomes:
measure: AUC: the area under the concentration-time curve
timeFrame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
measure: Cmax: maximum plasma concentration
timeFrame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
measure: Tmax: the time point of maximum plasma concentration
timeFrame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
Secondary outcomes:
measure: Alanine aminotransferase (ALT)
timeFrame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
measure: Aspartate aminotransferase (AST)
timeFrame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
measure: Alkaline phosphatase (ALP)
timeFrame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
measure: Bilirubin
timeFrame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
measure: Serum creatinine
timeFrame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
measure: Blood urea nitrogen (BUN)
timeFrame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
measure: Glomerular filtration rate (GFR)
timeFrame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
measure: C-reactive protein (CRP)
timeFrame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
measure: White blood cell count (WBC)
timeFrame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
measure: Hemoglobin (Hb)
timeFrame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
measure: Hematocrit (Hct)
timeFrame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
measure: Platelet count
timeFrame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
measure: Fasting blood glucose
timeFrame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
measure: Total cholesterol
timeFrame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
measure: Low-density lipoprotein (LDL) cholesterol
timeFrame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
measure: High-density lipoprotein (HDL) cholesterol
timeFrame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
measure: Triglycerides
timeFrame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Other outcomes:
Locations:
city: Burnaby
country: Canada
facility: ISURA
state: British Columbia
Study officials:
affiliation: Isura
name: Julia Solnier, PhD
role: PRINCIPAL_INVESTIGATOR
References: