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.
Male participants, aged 18 to 65 years (inclusive) at the time of informed consent.
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/or before first IP administration.
BMI ≥ 18.0 and ≤ 32.0 kg/m² and weight ≥ 50 kg.
Nonsmoker or casual smoker (< 5 cigarettes/week equivalent) with no tobacco use within 2 months prior to Screening (Investigator discretion).
Physical or psychological condition that would impair protocol compliance or study completion (Investigator judgement).
History of, or condition that would contraindicate study medication or interfere with study evaluations (Investigator judgement).
Previous history of any of: myocardial infarction; cerebrovascular accident; arrhythmia; congestive heart failure; unstable angina; recent (<6 months) need for calcium-channel/beta-blocker/nitrate/anti-epileptic therapy; uncontrolled hypertension (SBP >140 or DBP >100 mmHg); hypotension (SBP <90 or DBP <60 mmHg) incl. syncope/orthostatic/vasovagal; pulmonary/pericardial/retroperitoneal fibrotic disorders; sickle-cell disease or trait; cardiac valve disease; severe psychiatric disorders; Raynaud's/vasospastic disorders; bariatric surgery (cholecystectomy acceptable).
Blood/plasma donation or significant blood loss (450 mL) within 30 days prior to first IP dose.
Sequential
Viaca
Drugfixed-dose oral tablet of sildenafil + cabergoline (low-dose 25/0.25 mg; high-dose 50/0.5 mg). Single oral dose.
Sildenafil 50 mg
Drugsingle oral dose
Cabergoline 0.5 MG
Drugsingle oral dose
Participants with AEs/SAEs
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). Unit: participants (summarised by severity and relatedness).
Blood pressure
Change from Baseline in systolic and diastolic blood pressure. Unit: mmHg.
Pulse rate
Change from Baseline in pulse rate. Unit: beats/min.
Respiratory rate
Change from Baseline in respiratory rate. Unit: breaths/min.
Cmax
Maximum observed plasma concentration (Cmax). Unit: e.g. ng/mL.
Tmax
Time to maximum plasma concentration (Tmax). Unit: hours.
AUC0-t
Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC0-t). Unit: e.g. ng·h/mL.
AUC0-24
AUC from time 0 to 24 hours (AUC0-24). Unit: e.g. ng·h/mL.
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Yanping Kong
Lead sponsor
Kong's Pharmaceutical
Sponsor institution
Novotech (Australia) Pty Limited
Collaborator
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