NCT04071080

CompletedPhase 1

The Study of Oral Fluorescite to Confirm the Authenticity of...

UpTru Inc.Source

UpTru Inc.

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

PH1.20180001

Study Type

interventional

Actual enrollment (reported)

40

Locations

1 country

Sites

1

Timeline

Study Start

August 22, 2019

Actual (reported)

Primary Completion

November 28, 2019

Actual (reported)

Study Completion

November 28, 2019

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 40 participants
Study completion date: November 28, 2019
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
August 22, 2019
Actual (reported)
Study Start
August 22, 2019
Actual (reported)
First Posted
August 28, 2019
Actual (reported)
Primary Completion
November 28, 2019
Actual (reported)
Study Completion
November 28, 2019
Actual (reported)

Last Updated: January 6, 2020
Status Verified: January 2020
Last Update Submitted: January 2, 2020

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 sodiumDrug

Fluorescein sodium in 500mL Gatorade

Also known as: Fluorescite

100mg Fluorescein disodium

PlaceboDrug

500mL Gatorade

Placebo

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (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.

Sponsors & Collaborators

Medicor Research Inc.
Type not reportedcollaborator
UpTru Inc.
Industrylead

Study Sites (1)

Medicor Research Inc.

Greater Sudbury, Ontario, P3A 1W8, Canada

MeSH Terms

Interventions

Fluorescein

Intervention Hierarchy (Ancestors)

FluoresceinsSpiro CompoundsHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsXanthenesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPolycyclic Compounds

Enrollment

40 participants (actual enrollment reported by the registry).

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

Actual (reported)

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Phase 2Recruiting

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Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions

Phase 4Unknown

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Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions

Phase 4Terminated

NCT03752203

Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors

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Not ApplicableRecruiting

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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).

Contact the study team to confirm eligibility.

Primary Completion

November 28, 2019

Actual (reported)

Study Completion

November 28, 2019

Actual (reported)

Last Updated

January 6, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04071080
Data provider: ClinicalTrials.gov
Source updated: 2020-01-06
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:20:40 UTC

Locations

CA(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

100mg Fluorescein disodium

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations