[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Yanping Kong\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":54},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":5},"100649204","phase-1-a-study-to-assess-the-safety-tolerability-and-pharmacokinetics-of-viaca-sildenafil--cabergoline-compared-with-sildenafil-and-cabergoline-100649204",false,"NCT07732387","A Study to Assess the Safety, Tolerability and Pharmacokinetics of Viaca (Sildenafil + Cabergoline) Compared With Sildenafil and Cabergoline","An Open-Label Single-Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of Viaca (Sildenafil + Cabergoline) Compared With Sildenafil and Cabergoline in Healthy Volunteers","Inclusion Criteria:\n\n* Male participants, aged 18 to 65 years (inclusive) at the time of informed consent.\n* In good general health (Investigator judgement) with no significant medical history and no clinically significant abnormalities on physical examination, vital signs, or 12-lead ECG - including systolic blood pressure 110-140 mmHg (inclusive) at Screening and Day -1 - at Screening and\u002For before first IP administration.\n* BMI ≥ 18.0 and ≤ 32.0 kg\u002Fm² and weight ≥ 50 kg.\n* Nonsmoker or casual smoker (\\\u003C 5 cigarettes\u002Fweek equivalent) with no tobacco use within 2 months prior to Screening (Investigator discretion).\n* Clinical laboratory values within normal range (or not clinically significant per Investigator).\n* Fertile men agree to acceptable contraception from Screening until 90 days after last IP dose, and no sperm donation from first dose until ≥ 90 days after last dose.\n* Able and willing to attend required study visits.\n* Able and willing to provide written informed consent before any study procedures.\n\nExclusion Criteria:\n\n* Physical or psychological condition that would impair protocol compliance or study completion (Investigator judgement).\n* History of, or condition that would contraindicate study medication or interfere with study evaluations (Investigator judgement).\n* Previous history of any of: myocardial infarction; cerebrovascular accident; arrhythmia; congestive heart failure; unstable angina; recent (\\\u003C6 months) need for calcium-channel\u002Fbeta-blocker\u002Fnitrate\u002Fanti-epileptic therapy; uncontrolled hypertension (SBP \\>140 or DBP \\>100 mmHg); hypotension (SBP \\\u003C90 or DBP \\\u003C60 mmHg) incl. syncope\u002Forthostatic\u002Fvasovagal; pulmonary\u002Fpericardial\u002Fretroperitoneal fibrotic disorders; sickle-cell disease or trait; cardiac valve disease; severe psychiatric disorders; Raynaud's\u002Fvasospastic disorders; bariatric surgery (cholecystectomy acceptable).\n* Blood\u002Fplasma donation or significant blood loss (450 mL) within 30 days prior to first IP dose.\n* Fever (\\>38°C) or symptomatic viral\u002Fbacterial infection within 2 weeks prior to Screening.\n* Infections requiring parenteral antibiotics within 1 month prior to Screening.\n* Concomitant use of an indwelling urethral catheter.\n* Concomitant nitrates\u002Fnitric-oxide donors, potent CYP3A4 inhibitors (e.g. ritonavir, indinavir, ketoconazole) or moderate inhibitors (e.g. erythromycin); unwilling to avoid St. John's wort and CYP3A4-active herbals (e.g. grapefruit) within 14 days prior and throughout the study.\n* Medications that significantly affect BP: nitrates (any form), alpha-blockers (e.g. doxazosin, terazosin, tamsulosin), guanylate cyclase stimulators (e.g. riociguat).\n* Positive HCV antibody, HBsAg, or HIV antibody.\n* Live vaccine within 4 weeks prior to first IP dose.\n* Poor pill-swallowing ability or poor venous access.\n* History of severe allergic\u002Fanaphylactic reactions or sensitivity to IP or constituents.\n* History of malignancy (except non-melanoma skin cancer excised \\>5 years prior to Screening).\n* Clinically significant abnormal Screening ECG (e.g. QRS ≥ 120 msec and\u002For QTcF \\> 450 msec, per Investigator).\n* History\u002Fevidence of renal disease or eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m² at Screening (2021 CKD-EPI creatinine equation).\n* Immunosuppressive drug exposure (incl. experimental therapies) within 4 months or 5 half-lives (whichever longer) prior to Screening.\n* Positive urine toxicology panel (barbiturates, THC, amphetamines\u002Fmethamphetamines, methadone, MDMA, phencyclidine, tricyclic antidepressants, benzodiazepines, opiates, cocaine) or positive alcohol breath test.\n* Unwilling to abstain from alcohol, caffeine and nicotine from 48 h prior to admission, during confinement, and 48 h prior to follow-up visits.\n* History of substance abuse\u002Fdependency or recreational IV drug use in the last 12 months (self-declared).\n* Unwilling to refrain from strenuous exercise (incl. weightlifting) 48 h prior to admission and follow-up visits.\n* Anything the Investigator considers would jeopardize participant safety, prevent full participation, or compromise data interpretation.",true,"MALE","18 Years","65 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a Phase 1, open-label, single-ascending-dose study evaluating the safety, tolerability, and pharmacokinetics (PK) of Viaca - a fixed-dose oral combination of sildenafil (a PDE5 inhibitor) and cabergoline (a dopamine D2 agonist) - versus sildenafil monotherapy and cabergoline monotherapy in healthy adult male volunteers. Approximately 30 participants are enrolled across 5 sequential cohorts (6 each). Each participant receives a single oral dose. The combination targets erectile dysfunction through both vascular and neuroendocrine pathways, aiming for efficacy at lower component doses.",[28,29],"Erectile Dysfunctions","Healthy Volunteer",[31,32,33,34,35,36,37,38,39,40,41],"viaca","sildenafil","cabergoline","erectile dysfunction","PDE5 inhibitor","dopamine agonist","fixed-dose combination","single ascending dose","pharmacokinetics","healthy volunteers","Phase 1","NOT_YET_RECRUITING","2026-07-23",{"date":45,"type":46},"2026-07-28","ACTUAL",{"date":48,"type":22},"2026-08-01",{"date":50,"type":22},"2026-09-19",{"name":52,"class":53},"Yanping Kong","INDUSTRY",""]