Safety Evaluation of β-arbutin in Healthy Human Subjects

NCT03868748 | Completed Phase 1

• 1 other identifier: 241603
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of Adverse Events (AE)

  Number of treatment emergent adverse events according to CTCAE v5.0.

  During treatment period (Day 1 to Day 84)

Secondary Outcomes (6)

• Participant compliance to treatment

  During treatment period (day 7, day 28, day 56, day 84)

• Hematology

  At screening and during treatment period (day 7, day 28, day 56, day 84)

• Biochemistry

  At screening and during treatment period (day 7, day 28, day 56, day 84)

• Urinalysis (Routine)

  At screening and during treatment period (day 7, day 28, day 56, day 84)

• Urinalysis (Microscopy)

  At screening and during treatment period (day 7, day 28, day 56, day 84)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

The double-blind phase of the study starts with randomized allocation of eligible participants to one of three treatment arms. Participants randomized to the placebo treatment arm will consume one placebo capsule per day for 12 weeks

Other: Placebo

Low Dose, 12 weeks

EXPERIMENTAL

The double-blind phase of the study starts with randomized allocation of eligible participants to one of three treatment arms. Participants randomized to the low dose treatment arm will consume one 150 mg beta-arbutin capsule per day for 12 weeks.

Dietary Supplement: Beta-arbutin; Other: Placebo

High Dose, 4 weeks

EXPERIMENTAL

The double-blind phase of the study starts with randomized allocation of eligible participants to one of three treatment arms. Participants randomized to the high dose treatment arm will consume one placebo capsule per day for 8 weeks followed by one 400 mg beta-arbutin capsule per day for 4 weeks.

Dietary Supplement: Beta-arbutin; Other: Placebo

Interventions

Beta-arbutin DIETARY_SUPPLEMENT

Beta-arbutin capsules

Also known as: SP001

High Dose, 4 weeks; Low Dose, 12 weeks

Placebo OTHER

Placebo capsules containing non-medicinal ingredients

High Dose, 4 weeks; Low Dose, 12 weeks; Placebo

Eligibility Criteria

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

You may qualify if:

• 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..

You may not qualify if:

• 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

Sponsors & Collaborators

• SP Nutraceuticals Inc.: lead
• Canadian Glycomics Network (GlycoNet): collaborator

Study Sites (2)

St Joseph's Health Care London, St. Joseph's Hospital

London, Ontario, N6A 4V2, Canada

Location

KGK Science

London, Ontario, N6A5R8, Canada

Location

MeSH Terms

Interventions

Arbutin

Intervention Hierarchy (Ancestors)

Glucosides; Glycosides; Carbohydrates

Study Officials

• Hassan Razvi, MD, FRCSC

  Chair/Chief, Division of Urology

  PRINCIPAL INVESTIGATOR

• David Crowley, MD

  KGK Science site qualified investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: March 11, 2019
• Study Start: October 23, 2019
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: May 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)