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Safety Evaluation of β-arbutin in Healthy Human Subjects

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ClinicalTrials.gov Identifier: NCT03868748
Recruitment Status : Recruiting
First Posted : March 11, 2019
Last Update Posted : June 28, 2019
Sponsor:
Collaborator:
Canadian Glycomics Network (GlycoNet)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Dietary Supplement: Beta-arbutin Other: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Safety Evaluation of β-arbutin in Healthy Human Subjects
Estimated Study Start Date : June 20, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Arbutin

Arm Intervention/treatment
Placebo Comparator: 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
Other: Placebo
Placebo capsules containing non-medicinal ingredients

Experimental: 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.
Dietary Supplement: Beta-arbutin
Beta-arbutin capsules
Other Name: SP001

Other: Placebo
Placebo capsules containing non-medicinal ingredients

Experimental: 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.
Dietary Supplement: Beta-arbutin
Beta-arbutin capsules
Other Name: SP001

Other: Placebo
Placebo capsules containing non-medicinal ingredients




Primary Outcome Measures :
  1. Incidence and severity of Adverse Events (AE) [ Time Frame: During treatment period (Day 1 to Day 84) ]
    Number of treatment emergent adverse events according to CTCAE v5.0.


Secondary Outcome Measures :
  1. Participant compliance to treatment [ Time Frame: During treatment period (day 7, day 28, day 56, day 84) ]
    Adherence to study protocol and study product consumption as ascertained by capsule counts

  2. Hematology [ Time Frame: At screening and during treatment period (day 7, day 28, day 56, day 84) ]
    Number of clinically relevant changes in hematology markers as assessed by: hematocrit (HCT), hemoglobin (Hb), red blood cell count (RBC), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), white blood cell count (WBC), differential blood count (neutrophils, lymphocytes, monocytes, eosinophils and basophils), reticulocytes absolute count, and mean platelet volume (MPV). Assessments will be performed at screening and during treatment period.

  3. Biochemistry [ Time Frame: At screening and during treatment period (day 7, day 28, day 56, day 84) ]
    Number of clinically relevant changes in serum biochemistry. Enzymes: aspartate transaminase, alanine transaminase, alkaline phosphatase, gamma amyl transferase. Electrolytes: magnesium, sodium, potassium, chloride, calcium. Substrates: glucose (non-fasted), bilirubin (total, direct and indirect), creatinine, albumin, urea, vitamin D. Hormones: parathyroid hormone, thyroid stimulating hormone (TSH). Coagulation tests: international normalized ratio (INR), partial thromboplastin time (PTT). Assessments will be performed at screening and during treatment period.

  4. Urinalysis (Routine) [ Time Frame: At screening and during treatment period (day 7, day 28, day 56, day 84) ]
    Number of clinically relevant changes in routine dipstick urinalysis which will assess: pH, specific gravity, protein, glucose, ketones, blood, nitrite, and bilirubin. Assessments will be performed at screening and during treatment period.

  5. Urinalysis (Microscopy) [ Time Frame: At screening and during treatment period (day 7, day 28, day 56, day 84) ]
    Microscopy (RBC, WBC and casts [Hyaline, Granular and Cellular]) by thermodilatometry (TDL) may be performed at additional urinalysis time points if clinically relevant abnormalities are detected (positive result for protein or blood in dipstick). Assessments will be performed at screening and during treatment period.

  6. Urine culture [ Time Frame: At screening and during treatment period (day 7, day 28, day 56, day 84) ]
    Urine culture will be performed to detect microorganisms. Assessments will be performed at screening and during treatment period.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03868748


Contacts
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Contact: Urology Research 519-646-6310 Urology.Research@sjhc.london.on.ca

Locations
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Canada, Ontario
St Joseph's Health Care London, St. Joseph's Hospital Recruiting
London, Ontario, Canada, N6A 4V2
Principal Investigator: Hassan Razvi, MD, FRCSC         
Sub-Investigator: John D Denstedt, MD, FRCSC, FACS, FCAHS         
Sub-Investigator: Jennifer Bjazevic, MD         
Sponsors and Collaborators
SP Nutraceuticals Inc.
Canadian Glycomics Network (GlycoNet)

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Responsible Party: SP Nutraceuticals Inc.
ClinicalTrials.gov Identifier: NCT03868748     History of Changes
Other Study ID Numbers: 241603
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No