[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06585163":3,"trial-entities:NCT06585163":120,"trial-summary:NCT06585163":123},{"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":21,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":51,"secondary_outcomes":56,"sex":67,"minimum_age":68,"maximum_age":69,"healthy_volunteers":70,"eligibility_criteria":71,"std_ages":101,"locations":103,"central_contacts":113,"overall_officials":114,"references":118,"see_also_links":119},"NCT06585163","QEV-817-101","Study to Investigate the Safety, Tolerability and Pharmacokinetics of QEV-817 Oral Suspension","A Phase 1, Randomized, Open Label, Crossover Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of QEV-817 Oral Suspension in Healthy Volunteers","COMPLETED","2025-11-26","2026-07","2026-08-05","2025-08-18","Quivive Pharma, Inc.","INDUSTRY",false,"This study has been designed to assess the safety, tolerability, and pharmacokinetics of a therapeutic dose of hydrocodone bitartrate with and without an oral dose of doxapram hydrochloride in healthy volunteers who are naltrexone-blocked.","This is a Phase 1, single-center, randomized, open label, crossover study that will be conducted in male and female healthy volunteers. The study will be conducted at a single site in the US. The study consists of a 28-day Screening Period, a four-day treatment period, and a one-day safety follow-up period.\n\nThe study will be conducted in eight (8) healthy male and female subjects. Up to an additional five (5) subjects may be enrolled as alternates to replace dropouts. Subjects will be randomized (1:1) to one of two crossover treatment sequences.\n\nSubjects will receive either a fixed therapeutic dose of oral hydrocodone bitartrate alone or in combination with a fixed dose of oral doxapram hydrochloride. Prior to treatment, all subjects will receive naltrexone (opioid antagonist) to block opioid effects (i.e., naltrexone block).\n\nSafety will be evaluated by monitoring the nature, severity, and incidence of adverse events (AEs); and changes from baseline in physical examination, vital signs, 12-lead electrocardiogram (ECG) assessment, pulse oximetry, and clinical laboratory tests.\n\nPharmacokinetics of both drugs and their primary metabolites will be assessed in plasma samples collected through 24 hours post-dose from all subjects.",[19,20],"Healthy","PK Drug-drug Interaction Study",[22,23,24,25,26,27],"pharmacokinetics","hydrocodone","doxapram","oral","safety","tolerability","INTERVENTIONAL","BASIC_SCIENCE",[31],"PHASE1",{"count":33,"type":34},8,"ACTUAL",[36,45],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":43},"DRUG","Hydrocodone Bitartrate","Hydrocodone bitartrate oral suspension",[41,42],"Sequence A - Hydrocodone alone followed by combined (hydrocodone + doxapram)","Sequence B - Combined (hydrocodone + doxapram) followed by hydrocodone alone",[44],"NDC 51634-0014",{"type":37,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"Hydrocodone Bitartrate + Doxapram Hydrochloride","Doxapram hydrocholoride oral suspension",[41,42],[50,44],"NDC 10920-601",[52],{"measure":53,"description":54,"timeFrame":55},"Number of Participants With Abnormal Laboratory Assessments, 12-Lead Electrocardiogram (ECG), and Vital Signs","Number of participants with clinically meaningful changes from baseline in physical examination, vital signs, 12-lead ECG assessment and\u002For pulse oximetry","Day 1 to Day 5",[57,61,64],{"measure":58,"description":59,"timeFrame":60},"Plasma PK Parameters (Cmax)","Maximal plasma concentrations for hydrocodone","Day 2 and Day 4",{"measure":62,"description":63,"timeFrame":60},"Plasma PK Parameter (AUC0-24h)","Plasma area under the curve from 0 to 24h for hydrocodone",{"measure":65,"description":66,"timeFrame":60},"Plasma PK Parameter (Tmax)","Time to maximal plasma concentrations for hydrocodone","ALL","18 Years","55 Years",true,{"inclusion":72,"exclusion":82,"raw_text":100},[73,74,75,76,77,78,79,80,81],"Male or female aged 18-55 years, inclusive, on the day of screening.","Willing to abstain from alcohol and strenuous physical activity (i.e., strenuous, or unaccustomed weightlifting, running, bicycling, etc.) from 48 hours prior to study treatment administration until discharge from the clinical unit and prior to each outpatient visit.","Have normal laboratory values, as defined per protocol, at screening.","Absence of cardiac arrythmias, as well as corrected QT interval (QTc) \\\u003C 450 ms in males and QTc \\\u003C 460 ms in females based on 12-lead ECG findings at screening.","Body weight ≥50 kg and body mass index (BMI) within the range of 19-32 kg\u002Fm2 (inclusive).","Has never used opioids for non-therapeutic purposes (i.e., for recreational effects). Subjects with a history of valid medical use under prescription must have not used an opioid for at least three (3) months prior to Day 1.","Women of childbearing potential (WOCBP), as defined in Section 10.4, must have a negative serum pregnancy test within one (1) week AND a negative urine pregnancy test on Day 2, prior to the start of study treatment; Must not be breastfeeding, lactating, or planning a pregnancy during the study and for at least 32 days (5 half-lives plus 30-days) after the last dose of study intervention","Postmenopausal females must have a documented serum follicle-stimulating hormone (FSH) level \\>40 mIU\u002FmL (milli international units per milliliter) at screening to confirm menopause.","Male participants with female sexual partners who are WOCBP must agree to remain abstinent (complete avoidance of heterosexual intercourse) or use adequate contraceptive methods, defined as use of a condom by the male partner combined with use of a highly effective method of contraception by the female partner, during the treatment period and for at least 92 days (5 half-lives + 90-day spermatogenesis cycle) after the last dose of study intervention; must not donate sperm for at least 92 days (5 half-lives + 90-day spermatogenesis cycle) after the last dose of study intervention.",[83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99],"Female subject who is pregnant or lactating.","Have any vital sign abnormalities as described in the protocol.","Recreational opioid user who has used opioids for non-therapeutic purposes (i.e., for psychoactive effects) or who is physically dependent on any illicit or prescription opioid, and\u002For currently participating in a treatment program for individuals with opioid dependence.","Known allergy or history of significant adverse reaction to hydrocodone or its metabolites, other opioids, or related compounds, doxapram hydrochloride, naltrexone, naloxone, or to any of the excipients in QEV-817.","History of or currently has hypoventilation syndrome or sleep apnea and is on non-invasive ventilation (e.g., CPAP).","Clinically meaningful infection\u002Finjury\u002Fillness within one month prior to screening.","Active malignancy (excluding squamous or basal cell carcinoma of the skin) within 5 years of screening.","Subjects with hepatic impairment as defined by screening alanine transaminase (ALT), aspartate transaminase (AST) or total bilirubin \\>3× upper limit of normal (ULN).","Subjects with renal impairment as defined by screening estimated creatinine clearance\u002FeGFR (estimated glomerular filtration rate) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation is \\\u003C60 mL\u002Fmin\u002F1.73 m2.","Donation of blood (\\>450 mL) or significant blood loss within 56 days.","Current (or recent history of) psychiatric illness or mental impairment.","Clinically meaningful current (or history of) unstable chronic disease; medical abnormality; or significant cardiovascular (including significant cardiovascular impairment, uncompensated heart failure, severe coronary artery disease, severe hypertension), endocrine, gastrointestinal, neurological disorder (including cognitive disorders); or metabolic disease.","Currently active (or history of) epilepsy, seizure disorder, serious head injury, cerebral vascular accident, or cerebral edema.","Current treatment with monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, sympathomimetic drugs, neuromuscular blocking agents, narcotics, antihistamines, antipsychotics, antianxiety agents, or other central nervous system (CNS) depressants.","Use of any prescription or over the counter (OTC) medications including food supplements and herbal medications (e.g., St. John's wort), with the exception of contraceptive medications or a daily multivitamin, within fourteen (14) days prior to study treatment administration. Use of CYP3A4 inhibitors or inducers is prohibited within 28 days prior to the first treatment and throughout the treatment and follow-up periods.","A positive urine drug, cotinine, or alcohol test at screening, excluding tetrahydro-cannabinol (THC) or cannabinoid metabolites.","Smokers or use of tobacco-containing products within 6 weeks of study drug administration.","Key Inclusion Criteria - include but are not limited to:\n\n* Male or female aged 18-55 years, inclusive, on the day of screening.\n* Willing to abstain from alcohol and strenuous physical activity (i.e., strenuous, or unaccustomed weightlifting, running, bicycling, etc.) from 48 hours prior to study treatment administration until discharge from the clinical unit and prior to each outpatient visit.\n* Have normal laboratory values, as defined per protocol, at screening.\n* Absence of cardiac arrythmias, as well as corrected QT interval (QTc) \\\u003C 450 ms in males and QTc \\\u003C 460 ms in females based on 12-lead ECG findings at screening.\n* Body weight ≥50 kg and body mass index (BMI) within the range of 19-32 kg\u002Fm2 (inclusive).\n* Has never used opioids for non-therapeutic purposes (i.e., for recreational effects). Subjects with a history of valid medical use under prescription must have not used an opioid for at least three (3) months prior to Day 1.\n* Women of childbearing potential (WOCBP), as defined in Section 10.4, must have a negative serum pregnancy test within one (1) week AND a negative urine pregnancy test on Day 2, prior to the start of study treatment; Must not be breastfeeding, lactating, or planning a pregnancy during the study and for at least 32 days (5 half-lives plus 30-days) after the last dose of study intervention\n* Postmenopausal females must have a documented serum follicle-stimulating hormone (FSH) level \\>40 mIU\u002FmL (milli international units per milliliter) at screening to confirm menopause.\n* Male participants with female sexual partners who are WOCBP must agree to remain abstinent (complete avoidance of heterosexual intercourse) or use adequate contraceptive methods, defined as use of a condom by the male partner combined with use of a highly effective method of contraception by the female partner, during the treatment period and for at least 92 days (5 half-lives + 90-day spermatogenesis cycle) after the last dose of study intervention; must not donate sperm for at least 92 days (5 half-lives + 90-day spermatogenesis cycle) after the last dose of study intervention.\n\nExclusion Criteria - include but are not limited to:\n\n* Female subject who is pregnant or lactating.\n* Have any vital sign abnormalities as described in the protocol.\n* Recreational opioid user who has used opioids for non-therapeutic purposes (i.e., for psychoactive effects) or who is physically dependent on any illicit or prescription opioid, and\u002For currently participating in a treatment program for individuals with opioid dependence.\n* Known allergy or history of significant adverse reaction to hydrocodone or its metabolites, other opioids, or related compounds, doxapram hydrochloride, naltrexone, naloxone, or to any of the excipients in QEV-817.\n* History of or currently has hypoventilation syndrome or sleep apnea and is on non-invasive ventilation (e.g., CPAP).\n* Clinically meaningful infection\u002Finjury\u002Fillness within one month prior to screening.\n* Active malignancy (excluding squamous or basal cell carcinoma of the skin) within 5 years of screening.\n* Subjects with hepatic impairment as defined by screening alanine transaminase (ALT), aspartate transaminase (AST) or total bilirubin \\>3× upper limit of normal (ULN).\n* Subjects with renal impairment as defined by screening estimated creatinine clearance\u002FeGFR (estimated glomerular filtration rate) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation is \\\u003C60 mL\u002Fmin\u002F1.73 m2.\n* Donation of blood (\\>450 mL) or significant blood loss within 56 days.\n* Current (or recent history of) psychiatric illness or mental impairment.\n* Clinically meaningful current (or history of) unstable chronic disease; medical abnormality; or significant cardiovascular (including significant cardiovascular impairment, uncompensated heart failure, severe coronary artery disease, severe hypertension), endocrine, gastrointestinal, neurological disorder (including cognitive disorders); or metabolic disease.\n* Currently active (or history of) epilepsy, seizure disorder, serious head injury, cerebral vascular accident, or cerebral edema.\n* Current treatment with monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, sympathomimetic drugs, neuromuscular blocking agents, narcotics, antihistamines, antipsychotics, antianxiety agents, or other central nervous system (CNS) depressants.\n* Use of any prescription or over the counter (OTC) medications including food supplements and herbal medications (e.g., St. John's wort), with the exception of contraceptive medications or a daily multivitamin, within fourteen (14) days prior to study treatment administration. Use of CYP3A4 inhibitors or inducers is prohibited within 28 days prior to the first treatment and throughout the treatment and follow-up periods.\n* A positive urine drug, cotinine, or alcohol test at screening, excluding tetrahydro-cannabinol (THC) or cannabinoid metabolites.\n* Smokers or use of tobacco-containing products within 6 weeks of study drug administration.",[102],"ADULT",[104],{"facility":105,"city":106,"state":107,"zip":108,"country":109,"geoPoint":110},"Frontage Clinical Services, Inc.","Secaucus","New Jersey","07094","United States",{"lat":111,"lon":112},40.78955,-74.05653,[],[115],{"name":116,"affiliation":105,"role":117},"Frank Lee, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":121,"biomarkers":122},[19],[],{"nct_id":4,"found":70,"summary":124,"prompt_version":135},{"design":125,"status":126,"heading":127,"summary":128,"follow_up":129,"word_count":130,"commitments":131,"compensation":132,"drugs_mentioned":133},"This is a Phase 1, double-blind, randomized crossover study involving 8 healthy male and female volunteers at a single site in the US.","completed","Study of QEV-817 Oral Suspension with Hydrocodone and Doxapram","This study is looking at the safety and how well your body handles two medicines: hydrocodone bitartrate and doxapram hydrochloride. Researchers want to see if combining these medicines, or giving hydrocodone alone, causes any side effects in healthy volunteers. Before receiving the study medicines, all participants will be given naltrexone, which blocks the effects of opioids. The study will also measure how the medicines move through your body. To be in the study, you need to be a healthy adult between 18 and 55 years old. The main goals are to track any side effects and changes in lab tests, heart readings (ECG), and vital signs (like blood pressure and heart rate) from Day 1 to Day 5. The study is currently unclear on its recruitment status and plans to enroll 8 participants.","Participants will have a one-day safety follow-up after the treatment period, and safety will be monitored from Day 1 to Day 5.",133,"You would participate in a 28-day screening period, a four-day treatment period, and a one-day safety follow-up period. You would also need to avoid alcohol and strenuous exercise for 48 hours before treatment and until discharge.","Not stated in the trial record.",[38,134],"Doxapram Hydrochloride","v2"]