The Study of Oral Fluorescite to Confirm the Authenticity of Point of Care Urine Samples

A Phase I, Randomized, Double-blind, Placebo-controlled Study of Oral Fluorescite to Confirm the Authenticity of Point of Care Urine Samples

During this study, participants will ingest 100 mg of fluorescein disodium or a placebo (no drug) mixed in GatoradeTM. Participants will then provide a urine sample after 10, 15, 20 or 30 minutes to see if the investigator can detect fluorescein fluorescence (light) in the urine.

Study Overview

• Status: Completed
• Conditions: Urine Sample Authenticity
• Intervention / Treatment: Drug: fluorescein sodium; Drug: Placebo

Detailed Description

Every year, millions of dollars are spent on urine drug testing. Urine samples are generally provided in an unwitnessed fashion. Only a small percentage of samples involve direct observation of urination. The authenticity of the provided sample greatly affects its clinical utility and/or the validity of the test results. Direct observation of urination can be unpleasant and humiliating for people. For the institution, there are increased costs (for example, staff, insurance) and risks regarding impropriety when direct observation is utilized.

Participants are being asked to take part in a research study of an approved drug called FluoresciteTM. FluoresciteTM is an intravenous drug (administered into a vein) that has been approved by Health Canada. The active ingredient in FluoresciteTM is fluorescein disodium (10% fluorescein disodium in sterile water).

Fluorescein disodium has been used medically for over fifty years. It is a fluorophore (emits light, similar to a yellow glowstick) that is most commonly used in ophthalmology (the study and treatment of disorders and diseases of the eye). It is currently used in angiography (to view blood vessels), or topically for staining the eye's cornea. FluoresciteTM or fluorescein disodium has not been approved by Health Canada for oral administration.

During this study, participants will ingest 100 mg of fluorescein disodium or a placebo (no drug) mixed in GatoradeTM. The Investigator will then ask the participant to provide a urine sample after 10, 15, 20 or 30 minutes to see if he can detect fluorescence (light) in the urine.

The purpose of this study is to:

• Develop a new standardized protocol for urine sampling that will increase sample authenticity and make the situation between the patient/physician more pleasant.
• To evaluate the safety and tolerability of orally ingested fluorescein disodium.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Sudbury, Ontario, Canada, P3A 1W8
      • Medicor Research Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Willing and able to comply with visits and study procedures.
• Healthy males and females between the age of 18 and 55.

• Female subjects are eligible to participate if they are not pregnant, breastfeeding and at least one of the following conditions apply:

  • Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective (based on the investigator's judgment) for 28 days before/after study drug administration.
  • Is not of WOCBP (Postmenopausal and/or surgically sterile)
• Male subjects must use effective birth control methods and must not donate sperm until 2 weeks after treatment.

Exclusion Criteria:

• Staff members involved in the conduct of the study or their family members or site staff members supervised by the investigator. Subjects who are UPTru or Medicor employees, including their family members, directly involved in the conduct of the study are also not eligible to participate.
• Participants involved in any other study using an investigational product within 30 days or 5 half-lives (if known) prior to screening.

• Participants with any history of the following conditions:

  • Known history of allergy (such as food or drug-induced urticaria, asthma, eczema or allergic rhinitis) or known allergy to fluorescein disodium or any component of FluoresciteTM or GatoradeTM.
  • Jaundice, bronchial asthma, cirrhosis, uncontrolled diabetes (HbA1c ≥ 7.0), renal failure (calculated creatinine clearance of < 35 mL/min), cancer, HIV or hepatitis B/C.
• Participants with a life expectancy of fewer than 5 years.
• In the opinion of the investigator, any clinically significant abnormal ECG, vitals or laboratory result during screening that could put the participant at risk or affect the results of the study.
• Any concomitant medication that could potentially interact with the study drug or affect the results of the study (based on the investigator's opinion).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 100mg Fluorescein disodium; 100mg Fluorescein disodium will be mixed with 500mL of Gatorade and taken orally by the participant	Drug: fluorescein sodium; Fluorescein sodium in 500mL Gatorade; Other Names: Fluorescite
PLACEBO_COMPARATOR: Placebo; 500mL of Gatorade taken orally by the participant	Drug: Placebo; 500mL Gatorade

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients with detectable urine fluorescence using an ophtalmoscope equipped with a cobalt blue filter	Up to 24 weeks

Collaborators and Investigators

• Sponsor: UpTru Inc.
• Collaborators: Medicor Research Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 22, 2019
• Primary Completion (ACTUAL): November 28, 2019
• Study Completion (ACTUAL): November 28, 2019

Study Registration Dates

• First Submitted: August 22, 2019
• First Submitted That Met QC Criteria: August 26, 2019
• First Posted (ACTUAL): August 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 6, 2020
• Last Update Submitted That Met QC Criteria: January 2, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: PH1.20180001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes