Safety Evaluation of β-arbutin in Healthy Human Subjects

Safety Evaluation of β-arbutin in Healthy Human Subjects

Sponsors

Lead sponsor: SP Nutraceuticals Inc.

Collaborator: Canadian Glycomics Network (GlycoNet)

Source SP Nutraceuticals Inc.
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.

Overall Status Recruiting
Start Date October 23, 2019
Completion Date March 2021
Primary Completion Date March 2021
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence and severity of Adverse Events (AE) During treatment period (Day 1 to Day 84)
Secondary Outcome
Measure Time Frame
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)
Urine culture At screening and during treatment period (day 7, day 28, day 56, day 84)
Enrollment 30
Condition
Intervention

Intervention type: Dietary Supplement

Intervention name: Beta-arbutin

Description: Beta-arbutin capsules

Other name: SP001

Intervention type: Other

Intervention name: Placebo

Description: Placebo capsules containing non-medicinal ingredients

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);

- Ability to provide written informed consent; and

- Willing to 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;

- History of liver disease;

- Cancer being actively treated with systemic therapy (i.e. chemotherapy, immune therapy);

- 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; and

- Allergy to all ingredients (including non-medicinal ingredients) in investigational products and placebo product

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Hasan Razvi, MD, FRCSC Principal Investigator Chair/Chief, Division of Urology
Overall Contact

Last name: Urology Research

Phone: 519-646-6310

Email: [email protected]

Location
facility status investigator St Joseph's Health Care London, St. Joseph's Hospital Hassan Razvi, MD, FRCSC Principal Investigator John D Denstedt, MD, FRCSC, FACS, FCAHS Sub-Investigator Jennifer Bjazevic, MD Sub-Investigator
Location Countries

Canada

Verification Date

March 2020

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Number Of Arms 3
Arm Group

Arm group label: Placebo

Arm group type: Placebo Comparator

Description: 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

Arm group label: Low Dose, 12 weeks

Arm group type: Experimental

Description: 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.

Arm group label: High Dose, 4 weeks

Arm group type: Experimental

Description: 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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov