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

• ClinicalTrials.gov Identifier: NCT04071080
• Recruitment Status: Completed
• First Posted: August 28, 2019
• Last Update Posted: January 6, 2020
• Sponsor: UpTru Inc.
• Collaborator: Medicor Research Inc.
• Information provided by (Responsible Party): UpTru Inc.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Urine Sample Authenticity	Drug: fluorescein sodium; Drug: Placebo	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Screening
• Official Title: A Phase I, Randomized, Double-blind, Placebo-controlled Study of Oral Fluorescite to Confirm the Authenticity of Point of Care Urine Samples
• Actual Study Start Date: August 22, 2019
• Actual Primary Completion Date: November 28, 2019
• Actual Study Completion Date: November 28, 2019

Arms and Interventions

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 Name: Fluorescite
Placebo Comparator: Placebo; 500mL of Gatorade taken orally by the participant	Drug: Placebo; 500mL Gatorade

Outcome Measures

Primary Outcome Measures :

1. Percentage of patients with detectable urine fluorescence using an ophtalmoscope equipped with a cobalt blue filter [ Time Frame: Up to 24 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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).

Contacts and Locations

Locations

Canada, Ontario

Medicor Research Inc.

Sudbury, Ontario, Canada, P3A 1W8

Sponsors and Collaborators

UpTru Inc.

Medicor Research Inc.

More Information

• Responsible Party: UpTru Inc.
• ClinicalTrials.gov Identifier: NCT04071080
• Other Study ID Numbers: PH1.20180001
• First Posted: August 28, 2019
• Last Update Posted: January 6, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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