[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649204":3},{"organization":4,"armGroups":7,"interventions":33,"overallOfficials":47,"centralContacts":52,"locations":58,"responsibleParty":71,"collaborators":75,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":39,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":39,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":111,"whyStopped":39,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Kong's Pharmaceutical","INDUSTRY",[8,14,18,22,28],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1: Viaca 25\u002F0.25 mg","EXPERIMENTAL","Single oral dose of Viaca (sildenafil 25 mg \u002F cabergoline 0.25 mg; one low-dose tablet) in 6 healthy male participants.",[13],"Drug: Viaca",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2: Viaca 50\u002F0.5 mg","Single oral dose of Viaca (sildenafil 50 mg \u002F cabergoline 0.5 mg; one high-dose tablet",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort 3: Viaca 75\u002F0.75 mg","Single oral dose of Viaca (sildenafil 75 mg \u002F cabergoline 0.75 mg; one low + one high tablet",[13],{"label":23,"type":24,"description":25,"interventionNames":26},"Cohort 4: Sildenafil 50 mg","ACTIVE_COMPARATOR","Single oral dose of sildenafil 50 mg (two 25 mg tablets).",[27],"Drug: Sildenafil 50 mg",{"label":29,"type":24,"description":30,"interventionNames":31},"Cohort 5: Cabergoline 0.5 mg","Single oral dose of cabergoline 0.5 mg (one 0.5 mg tablet).",[32],"Drug: Cabergoline 0.5 MG",[34,40,44],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"DRUG","Viaca","fixed-dose oral tablet of sildenafil + cabergoline (low-dose 25\u002F0.25 mg; high-dose 50\u002F0.5 mg). Single oral dose.",[9,15,19],null,{"type":35,"name":41,"description":42,"armGroupLabels":43,"otherNames":39},"Sildenafil 50 mg","single oral dose",[23],{"type":35,"name":45,"description":42,"armGroupLabels":46,"otherNames":39},"Cabergoline 0.5 MG",[29],[48],{"name":49,"affiliation":50,"role":51},"Emma Trowbridge, MD","Nucleus Network Brisbane","PRINCIPAL_INVESTIGATOR",[53],{"name":54,"role":55,"phone":56,"phoneExt":39,"email":57},"Clinical Research Coordinator at Nucleus Network Brisbane","CONTACT","1800 243 733","brisbane@nucleusnetwork.com",[59],{"facility":50,"status":39,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":39},"Herston","Queensland","4006","Australia","AU",{"type":66,"coordinates":67},"Point",[68,69],153.01852,-27.44453,{"lat":69,"lon":68},{"type":72,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"SPONSOR_INVESTIGATOR","Yanping Kong","MD, PhD, President, Kong's Pharmaceutical Co.",[76],{"name":77,"class":6},"Novotech (Australia) Pty Limited","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":90,"type":91},30,"ESTIMATED","INTERVENTIONAL",[94],"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.",[97,98],"Erectile Dysfunctions","Healthy Volunteer",[100,101,102,103,104,105,106,107,108,109,110],"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":114,"type":115},"2026-07-28","ACTUAL",{"date":117,"type":91},"2026-08-01",{"date":119,"type":91},"2026-09-19",{"name":73,"class":6},1]