[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616214":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":11,"responsibleParty":26,"collaborators":11,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":11,"eligibilityCriteria":34,"healthyVolunteers":35,"sex":36,"minAge":37,"maxAge":38,"enrollmentInfo":39,"targetDuration":11,"studyType":42,"phases":43,"briefSummary":45,"conditions":46,"keywords":11,"overallStatus":48,"whyStopped":11,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":11},{"fullName":5,"class":6},"Aspargo Labs, Inc","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single-Arm Crossover","EXPERIMENTAL",null,[13],"Drug: Hezkue Oral Sildenafil Suspension",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","Hezkue Oral Sildenafil Suspension","Hezkue® oral sildenafil suspension will be administered as a single oral dose following controlled moderate alcohol consumption under fasting or standardized conditions, according to the study schedule, to evaluate pharmacokinetics, onset performance, and safety.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Avi Guralnik","CONTACT","17189381157","avi.berg@synergy-cro.com",{"type":27,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100616214","phase-1-pk-and-onset-of-hezkue-oral-sildenafil-suspension-after-alcohol-consumption-100616214",false,"NCT07302698","PK and Onset of Hezkue Oral Sildenafil Suspension After Alcohol Consumption","Evaluation of the Pharmacokinetics and Onset Performance of Hezkue® Oral Sildenafil Suspension Following Alcohol Consumption in Healthy Adults","Inclusion Criteria:\n\n* Male or female adults 21 to 55 years of age, inclusive.\n\nBody mass index (BMI) between 18.0 and 30.0 kg\u002Fm², inclusive.\n\nMedically healthy based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations, in the opinion of the investigator.\n\nAble to safely consume moderate amounts of alcohol as judged by the investigator (for example, no history of alcohol intolerance, alcohol use disorder, or alcohol-related medical complications).\n\nBlood pressure and heart rate within normal or non-clinically significant ranges at screening and baseline, in the opinion of the investigator.\n\nNon-smoker or light smoker (10 cigarettes per day or fewer, or equivalent) willing to abstain during study confinement periods.\n\nAble to understand and provide written informed consent before any study-specific procedures are performed.\n\nWilling and able to comply with all study requirements, including alcohol restrictions, fasting, dosing schedules, and pharmacokinetic and onset assessments.\n\nFemales of childbearing potential must use acceptable contraception as determined by the investigator.\n\nExclusion Criteria:\n\n* History or presence of any clinically significant cardiovascular disease, including but not limited to coronary artery disease, heart failure, clinically important arrhythmias, or uncontrolled hypertension or hypotension.\n\nResting systolic blood pressure or diastolic blood pressure, or heart rate, outside protocol-defined acceptable ranges at screening or baseline, in the opinion of the investigator.\n\nKnown hypersensitivity or contraindication to sildenafil, other phosphodiesterase type 5 (PDE5) inhibitors, alcohol, or any component of the study formulations.\n\nCurrent or recent use of nitrates, nitric oxide donors, or guanylate cyclase stimulators (for example, riociguat).\n\nHistory of significant hepatic, renal, gastrointestinal, neurologic, psychiatric, endocrine, hematologic, or respiratory disease that, in the investigator's opinion, could interfere with study participation or data interpretation.\n\nHistory of syncope, significant orthostatic hypotension, or other conditions that may be worsened by sildenafil or alcohol.\n\nHistory of alcohol use disorder, binge drinking patterns, or other substance use disorder, as determined by the investigator.\n\nPositive urine drug screen or positive alcohol test at screening (outside scheduled alcohol administration for the study) or at admission.\n\nUse of prescription or over-the-counter medications, herbal products, or dietary supplements within 14 days before the first study dose, unless considered acceptable by the investigator.\n\nPositive test for hepatitis B surface antigen, hepatitis C antibody, or HIV.\n\nParticipation in another clinical study or receipt of an investigational drug or device within 30 days or 5 half-lives (whichever is longer) before the first study dose.\n\nDonation of 450 mL or more of blood, or significant blood loss, within 8 weeks before the first study dose.\n\nPregnant or breastfeeding females.\n\nWomen of childbearing potential not using acceptable contraception.\n\nAny condition or circumstance that, in the opinion of the investigator, would make the participant unsuitable for the study or could interfere with compliance or study assessments.",true,"MALE","18 Years","70 Years",{"count":40,"type":41},24,"ESTIMATED","INTERVENTIONAL",[44],"PHASE1","This is an open-label, randomized study evaluating the pharmacokinetics and onset performance of Hezkue® oral sildenafil suspension administered following moderate alcohol consumption in healthy adult subjects. Participants will receive Hezkue® under controlled alcohol-exposure conditions. Pharmacokinetic sampling, onset assessments, and safety evaluations will be conducted throughout the study.",[47],"Healthy Volunteers","NOT_YET_RECRUITING","2025-12-11",{"date":51,"type":52},"2025-12-24","ACTUAL",{"date":54,"type":41},"2026-03-15",{"date":56,"type":41},"2026-05-28",{"name":5,"class":6}]