A Study to Assess the Safety, Tolerability and Pharmacokinetics of Viaca (Sildenafil + Cabergoline) Compared With Sildenafil and Cabergoline

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.

NCT Number	NCT07732387
Lead Sponsor	Yanping Kong Collaborators: Novotech (Australia) Pty Limited
Conditions	Erectile Dysfunctions, Healthy Volunteer
Enrollment	30 participants
Start Date	2026-08-01
Primary Completion	2026-09-19 (estimated)
Study Completion	2026-09-19 (estimated)
Updated on ClinicalTrials.gov	2026-07-28