RECRUITING

Drug Screening System Method Comparison

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Prospective, open-label, single-dose, randomized, multi-site performance evaluation of the accuracy and usability Intelligent Fingerprinting Drug Screening System in the hands of intended users: "operators" and "donors."

Official Title

User Performance Evaluation of the Intelligent Fingerprinting Drug Screening System: Method Comparison and Usability

Quick Facts

Study Start:2024-08-26

Study Completion:2024-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06618183

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Informed of the nature of the study, agreed to, and able to read, review, and sign the informed consent document prior to dosing. The informed consent document will be written in English; therefore, the subject must have the ability to read and communicate in English. 2. \Completed the screening process within 30 days prior to dosing. Subjects screened as a part of an IRB-approved General Screening Protocol at the clinical research site may be included in this study without additional screening procedures, provided all the required screening procedures have been performed within 30 days prior to dosing. 3. Healthy male and non-pregnant female subjects from ages 18 to 65, inclusive, at the time of dosing. 4. \Body mass index (BMI) from 18 kg/m2 to 30 kg/m2, inclusive, and weigh at least 60 kg. 5. \Females of childbearing potential must be willing to practice an acceptable form of contraception (see Section 9.3.3), and have a negative urine pregnancy test on admission to the treatment phase of the study. 6. \Males must agree to practice an acceptable form of contraception. 7. \*Judged by the Investigator and/or designee to be in good health as documented by the medical history, and vital sign assessments. Any abnormalities or deviations outside the normal range for vital signs can be repeated by clinical staff and judged to be not clinically significant for study participation.	1. Unwilling or unable to provide informed consent. 2. \More than three digits absent from the hands due to congenital or accidental cause(s). 3. \Reports receiving any investigational drug within 30 days prior to dosing. 4. \Reports a clinically significant illness during the 30 days prior to the in-clinic portion of the study (as determined by the Investigator). 5. \Reports any personal history of substance abuse (including drug/alcohol abuse or addiction) or mental illness (e.g. major depression) within one year prior to screening visit. 6. \Is pregnant (females only). 7. \Presence of any clinically significant results from laboratory tests and vital signs assessments, as judged by the Investigator. 8. \Reports history of respiratory depression (e.g., sleep apnea). 9. \Current severe hypotension (i.e., systolic blood pressure \<90 mmHg). 10. \Reports known or suspected gastrointestinal obstruction including, paralytic ileus. 11. \Reports current presence of acute bronchial asthma/ upper airway obstruction. 12. \Reports a history of clinically significant allergies, including food or drug allergies, as judged by the Investigator. 13. \Reports history or current condition of adrenal insufficiency. 14. \Reports history or current condition of renal disease. 15. If, in the opinion of the Investigator, the subject is not suitable for the study. Required only for \"donors.\" Not required for \"operators.\"

Inclusion Criteria

Exclusion Criteria

1. Informed of the nature of the study, agreed to, and able to read, review, and sign the informed consent document prior to dosing. The informed consent document will be written in English; therefore, the subject must have the ability to read and communicate in English.
2. \*Completed the screening process within 30 days prior to dosing. Subjects screened as a part of an IRB-approved General Screening Protocol at the clinical research site may be included in this study without additional screening procedures, provided all the required screening procedures have been performed within 30 days prior to dosing.
3. Healthy male and non-pregnant female subjects from ages 18 to 65, inclusive, at the time of dosing.
4. \*Body mass index (BMI) from 18 kg/m2 to 30 kg/m2, inclusive, and weigh at least 60 kg.
5. \*Females of childbearing potential must be willing to practice an acceptable form of contraception (see Section 9.3.3), and have a negative urine pregnancy test on admission to the treatment phase of the study.
6. \*Males must agree to practice an acceptable form of contraception.
7. \*Judged by the Investigator and/or designee to be in good health as documented by the medical history, and vital sign assessments. Any abnormalities or deviations outside the normal range for vital signs can be repeated by clinical staff and judged to be not clinically significant for study participation.

1. Unwilling or unable to provide informed consent.
2. \*More than three digits absent from the hands due to congenital or accidental cause(s).
3. \*Reports receiving any investigational drug within 30 days prior to dosing.
4. \*Reports a clinically significant illness during the 30 days prior to the in-clinic portion of the study (as determined by the Investigator).
5. \*Reports any personal history of substance abuse (including drug/alcohol abuse or addiction) or mental illness (e.g. major depression) within one year prior to screening visit.
6. \*Is pregnant (females only).
7. \*Presence of any clinically significant results from laboratory tests and vital signs assessments, as judged by the Investigator.
8. \*Reports history of respiratory depression (e.g., sleep apnea).
9. \*Current severe hypotension (i.e., systolic blood pressure \<90 mmHg).
10. \*Reports known or suspected gastrointestinal obstruction including, paralytic ileus.
11. \*Reports current presence of acute bronchial asthma/ upper airway obstruction.
12. \*Reports a history of clinically significant allergies, including food or drug allergies, as judged by the Investigator.
13. \*Reports history or current condition of adrenal insufficiency.
14. \*Reports history or current condition of renal disease.
15. If, in the opinion of the Investigator, the subject is not suitable for the study.
* Required only for \"donors.\" Not required for \"operators.\"

Contacts and Locations

Study Locations (Sites)

CenExel iResearch

Decatur, Georgia, 30030

United States

CenExel HRI

Berlin, New Jersey, 08009

United States

CenExel HRI

Marlton, New Jersey, 08053

United States

Collaborators and Investigators

Sponsor: Intelligent Bio Solutions Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-26

Study Completion Date2024-12-31

Study Record Updates

Study Start Date2024-08-26

Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

Reagent Kits, Diagnostic