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

NCT04071080 | Completed Phase 1 FDA Drug

• 1 other identifier: PH1.20180001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Urine Sample Authenticity

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with detectable urine fluorescence using an ophtalmoscope equipped with a cobalt blue filter

  Up to 24 weeks

Study Arms (2)

100mg Fluorescein disodium

EXPERIMENTAL

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

Drug: fluorescein sodium

Placebo

PLACEBO COMPARATOR

500mL of Gatorade taken orally by the participant

Drug: Placebo

Interventions

fluorescein sodium DRUG

Fluorescein sodium in 500mL Gatorade

Also known as: Fluorescite

100mg Fluorescein disodium

Placebo DRUG

500mL Gatorade

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• UpTru Inc.: lead
• Medicor Research Inc.: collaborator

Study Sites (1)

Medicor Research Inc.

Greater Sudbury, Ontario, P3A 1W8, Canada

Location

MeSH Terms

Interventions

Fluorescein

Intervention Hierarchy (Ancestors)

Fluoresceins; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 28, 2019
• Study Start: August 22, 2019
• Primary Completion: November 28, 2019
• Study Completion: November 28, 2019
• Last Updated: January 6, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)