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

• Status: Completed
• Trial end date: 2019-11-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: UpTru Inc.
• Collaborator: Medicor Research Inc.

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).