Clinical trial NCT03868748: Safety Evaluation of β-arbutin in Healthy Human Subjects
Official title: Safety Evaluation of β-arbutin in Healthy Human Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: SP Nutraceuticals Inc.
Sponsor class: INDUSTRY
Collaborators: name: Canadian Glycomics Network (GlycoNet)
First posted: 2019-03-11
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety of synthetic beta-arbutin, a dietary supplement that aids in the prevention and treatment of calcium oxalate kidney stones, when administered to healthy human subjects.

Detailed description: The objective and purpose of this Phase I study is to investigate the safety of synthetic beta-arbutin, administered to healthy human subjects for: i) 12 weeks, at a dose of 150 mg/day, and ii) 4 weeks, at a dose of 400mg/day. Safety will be determined by assessing adverse event rates between treatment groups and mean changes relative to baseline in serum biochemical, hematological and urinary markers.

Eligibility criteria: Inclusion Criteria:

* Adults, aged 18-65 years
* includes non-pregnant, non-breastfeeding women on adequate birth control
* acceptable effective contraceptive methods for participants with child-bearing potential include: barrier methods (condoms), total abstinence, hormonal birth control methods (oral, injectable, transdermal, or intra-vaginal), intrauterine devices, and confirmed successful vasectomy of partner;
* Body Mass Index (BMI) of 18.5-35 kg/m2;
* Generally healthy (absence of active clinical disease as determined by serum biochemical, hematological, and urinary parameter tests as well as detailed medical history and blood pressure measurements) as assessed by the PI/QI;
* Males and females of childbearing potential willing to use appropriate effective contraception for the duration of the study;
* Agrees to maintain current diet and exercise routine during the study;
* Ability to provide written informed consent; and
* Willing to comply with all study requirements and provide urine and blood specimens over the 12-week study period..

Exclusion Criteria:

* Pregnant or breastfeeding women;
* History of renal dysfunction;
* History of macular degeneration as assessed by the PI/QI;
* History of liver disease as assessed by the PI/QI;
* Type I or Type II diabetes;
* Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the PI/QI History of renal dysfunction, as assessed by the PI/QI;
* Cancer being actively treated with systemic therapy (i.e. chemotherapy, immune therapy);
* Self-reported HIV-, Hepatitis B-, and/or C-positive diagnosis;
* High alcohol intake (average of \> 2 standard drinks per day);
* Heavy smokers (average of \>10 cigarettes per day);
* Use of cannabinoid products within 30 days of enrollment;
* Any history of major surgery (i.e. inter-abdominal, inter-thoracic, inter-cranial) within the last six months, or surgery planned during the course of the study;
* Known hypersensitivity to arbutin;
* Allergy to all ingredients (including non-medicinal ingredients) in investigational products and placebo product
* Self-reported medical or neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation; and
* Clinically significant abnormal laboratory results at screening as assessed by the PI/QI

Primary outcomes:
measure: Incidence and severity of Adverse Events (AE)
timeFrame: During treatment period (Day 1 to Day 84)
Secondary outcomes:
measure: Participant compliance to treatment
timeFrame: During treatment period (day 7, day 28, day 56, day 84)
measure: Hematology
timeFrame: At screening and during treatment period (day 7, day 28, day 56, day 84)
measure: Biochemistry
timeFrame: At screening and during treatment period (day 7, day 28, day 56, day 84)
measure: Urinalysis (Routine)
timeFrame: At screening and during treatment period (day 7, day 28, day 56, day 84)
measure: Urinalysis (Microscopy)
timeFrame: At screening and during treatment period (day 7, day 28, day 56, day 84)
measure: Urine culture
timeFrame: At screening and during treatment period (day 7, day 28, day 56, day 84)
Other outcomes:
Locations:
city: London
country: Canada
facility: St Joseph's Health Care London, St. Joseph's Hospital
state: Ontario
city: London
country: Canada
facility: KGK Science
state: Ontario
Study officials:
affiliation: Chair/Chief, Division of Urology
name: Hassan Razvi, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: KGK Science site qualified investigator
name: David Crowley, MD
role: PRINCIPAL_INVESTIGATOR
References: