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

NCT ID: NCT04071080

Last Updated: 2020-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-22
• Study Completion Date: 2019-11-28

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.

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.

Conditions

Urine Sample Authenticity

Study Design

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

Study Groups

100mg Fluorescein disodium

100mg Fluorescein disodium will be mixed with 500mL of Gatorade and taken orally by the participant

Group Type: EXPERIMENTAL

fluorescein sodium

Intervention Type: DRUG

Fluorescein sodium in 500mL Gatorade

Placebo

500mL of Gatorade taken orally by the participant

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

500mL Gatorade

Interventions

fluorescein sodium

Fluorescein sodium in 500mL Gatorade

Intervention Type: DRUG

Placebo

500mL Gatorade

Intervention Type: DRUG

Other Intervention Names

Fluorescite

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medicor Research Inc.

UNKNOWN

Sponsor Role: collaborator

UpTru Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medicor Research Inc.

Greater Sudbury, Ontario, Canada

Countries

Canada

Other Identifiers

PH1.20180001

Identifier Type: -

Identifier Source: org_study_id