[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07650136":3,"trial-entities:NCT07650136":72,"trial-summary:NCT07650136":76},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":28,"secondary_outcomes":39,"sex":40,"minimum_age":41,"maximum_age":42,"healthy_volunteers":43,"eligibility_criteria":44,"std_ages":48,"locations":51,"central_contacts":65,"overall_officials":69,"references":70,"see_also_links":71},"NCT07650136","IBS-2025-03","Method Comparison of Intelligent Fingerprinting Drug Screening System","User Performance Evaluation of the Intelligent Fingerprinting Drug Screening System: Method Comparison","RECRUITING","2026-08-31","2026-07","2026-08-03","2026-06-02","Intelligent Bio Solutions Inc.","INDUSTRY",false,"Prospective, multi-site, open-label, single- or double-dose, randomized, multi-site performance evaluation of accuracy of the Intelligent Fingerprinting Drug Screening System in the hands of intended users: \"operators\" and \"donors.\"","This will be a study under non-fasting conditions. The total number of healthy adult \"operator\" subjects (male and non-pregnant females) required for enrollment in this study protocol is nine. The total number of healthy adult \"donor\" subjects (male and non-pregnant females) required for enrollment in this study protocol is 135. These subjects will be distributed across three sites with the recruiting goal of three operators and 45 subjects per site.\n\nSubjects will be recruited to participate as either \"operator\" or \"donor.\" The total duration of the study, from check-in through the end of the study will be approximately three days for \"operators\" with no overnight confinement, and one to eight hours for \"donors\" at two of the sites. At the third site, 31 \"donors\" will be dosed twice and will remain at the clinic overnight so that biological sampling can occur 24 hours after the first codeine dose. Because the \"operators\" are required to be at the clinic for three days, they may be recruited separately and compensated at a different rate than the \"donors.\" \"Operators\" may be employed by the clinic.\n\n\"Donors\" at sites 1 and 2 will be block randomized to one of two cohorts: no codeine dose or 60 mg codeine dose. The goal is to complete the study with approximately 69% of subjects in the 60 mg cohort. \"Donors\" at site 3 will be randomized into one of two cohorts: no codeine dose or two 60 mg doses. The cohort receiving two 60 mg codeine doses will be confined at the clinic overnight to enable additional biological sampling events.",[19],"Drug Abuse Illicit",[],"OBSERVATIONAL",null,[],{"count":25,"type":26},144,"ESTIMATED",[],[29,33,36],{"measure":30,"description":31,"timeFrame":32},"Sensitivity","Sensitivity of the Intelligent Fingerprinting DSC 7-Plus Drug Screening Cartridge for Codeine","24 hrs",{"measure":34,"description":35,"timeFrame":32},"Specificity","Specificity of the Intelligent Fingerprinting DSC 7-Plus Drug Screening Cartridge for Codeine",{"measure":37,"description":38,"timeFrame":32},"Accuracy","Accuracy of the Intelligent Fingerprinting DSC 7-Plus Drug Screening Cartridge for Codeine",[],"ALL","18 Years","65 Years",true,{"inclusion":45,"exclusion":46,"raw_text":47},[],[],"Inclusion Criteria:\n\n1\\. Able to provide informed consent 2. Completed the screening process within 30 days prior to dosing. 3. Healthy male and non-pregnant female subjects at the time of dosing. 4. Body mass index (BMI) from 18.0 kg\u002Fm2 to 32.0 kg\u002Fm2, inclusive 5. Weigh at least 60 kg. 5. Females of childbearing potential must be willing to practice an acceptable form of contraception, and have a negative urine pregnancy test on admission to the treatment phase of the study.\n\n6\\. Males must agree to practice an acceptable form of contraception 7. Judged by the Investigator and\u002For designee to be in good health as documented by the medical history, and vital sign assessments.\n\nExclusion Criteria:\n\n1. Unwilling or unable to provide informed consent.\n2. More than three digits absent from the hands due to congenital or accidental cause(s).\n3. Reports receiving any investigational drug within 30 days prior to dosing.\n4. Reports a clinically significant illness during the 30 days prior to the in-clinic portion of the study (as determined by the Investigator).\n5. Reports any personal history of substance abuse (including drug\u002Falcohol abuse or addiction) or mental illness (e.g. major depression) within one year prior to screening visit.\n6. Is pregnant (females only).\n7. Presence of any clinically significant results from laboratory tests and vital signs assessments, as judged by the Investigator.\n8. Reports history of respiratory depression (e.g., sleep apnea).\n9. Reports history of reaction to codeine (e.g., nausea, allergy).\n10. Current severe hypotension (i.e., systolic blood pressure \\\u003C90 mmHg).\n11. Reports known or suspected gastrointestinal obstruction including, paralytic ileus.\n12. Reports current presence of acute bronchial asthma\u002F upper airway obstruction.\n13. Reports a history of clinically significant allergies, including food or drug allergies, as judged by the Investigator.\n14. Reports history or current condition of adrenal insufficiency.\n15. Reports history or current condition of renal disease.\n16. If, in the opinion of the Investigator, the subject is not suitable for the study.",[49,50],"ADULT","OLDER_ADULT",[52],{"facility":53,"status":8,"city":54,"state":55,"zip":56,"country":57,"contacts":58,"geoPoint":62},"CenExel Clinical Research","Marlton","New Jersey","08053","United States",[59],{"name":60,"role":61},"Elan Cohen, PhD","CONTACT",{"lat":63,"lon":64},39.89122,-74.92183,[66],{"name":60,"role":61,"phone":67,"email":68},"856.452.9901","e.cohen@cenexel.com",[],[],[],{"nct_id":4,"conditions":73,"biomarkers":75},[74],"Healthy Volunteers",[],{"nct_id":4,"found":43,"summary":77,"prompt_version":87},{"design":78,"status":79,"heading":80,"summary":81,"follow_up":82,"word_count":83,"commitments":84,"compensation":85,"drugs_mentioned":86},"This is an observational study that will enroll 144 healthy adults, including 9 \"operators\" and 135 \"donors,\" across multiple sites. Some \"donors\" will be randomly assigned to receive a 60 mg dose of codeine, while others will not.","completed","Evaluating a Fingerprint Drug Screening System for Codeine","This study is evaluating a new fingerprint drug screening system to see how accurately it can detect codeine in sweat. Researchers will compare the results from this system to other methods. You may be able to join if you are a healthy adult between 18 and 65 years old, weigh at least 60 kg, and have a body mass index (BMI) between 18 and 32. The study aims to measure how sensitive, specific, and accurate the fingerprint system is at detecting codeine within 24 hours. The current status of this study is unclear.","The primary measurements for sensitivity, specificity, and accuracy will be taken at 24 hours after dosing.",93,"If you are a \"donor,\" your participation will last approximately one to eight hours, or up to three days with an overnight stay at one site. If you are an \"operator,\" you will be at the clinic for about three days.","Not stated in the trial record.",[],"v2"]