Safety Evaluation of β-arbutin in Healthy Human Subjects

NCT ID: NCT03868748

Last Updated: 2022-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-23
• Study Completion Date: 2021-03-01

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo capsules containing non-medicinal ingredients

Low Dose, 12 weeks

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.

Group Type: EXPERIMENTAL

Beta-arbutin

Intervention Type: DIETARY_SUPPLEMENT

Beta-arbutin capsules

Placebo

Intervention Type: OTHER

Placebo capsules containing non-medicinal ingredients

High Dose, 4 weeks

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.

Group Type: EXPERIMENTAL

Beta-arbutin

Intervention Type: DIETARY_SUPPLEMENT

Beta-arbutin capsules

Placebo

Intervention Type: OTHER

Placebo capsules containing non-medicinal ingredients

Interventions

Beta-arbutin

Beta-arbutin capsules

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo capsules containing non-medicinal ingredients

Intervention Type: OTHER

Other Intervention Names

SP001

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Glycomics Network (GlycoNet)

UNKNOWN

Sponsor Role: collaborator

SP Nutraceuticals Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hassan Razvi, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Chair/Chief, Division of Urology

David Crowley, MD

Role: PRINCIPAL_INVESTIGATOR

KGK Science site qualified investigator

Locations

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

London, Ontario, Canada

KGK Science

London, Ontario, Canada

Countries

Canada

Other Identifiers

241603

Identifier Type: -

Identifier Source: org_study_id