A Study to Assess the Safety, Tolerability and Pharmacokinetics of Viaca (Sildenafil + Cabergolin… (NCT07732387) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Viaca (Sildenafil + Cabergoline) Compared With Sildenafil and Cabergoline
Australia30 participantsStarted 2026-08-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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).
* Clinical laboratory values within normal range (or not clinically significant per Investigator).
* 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.
* Able and willing to attend required study visits.
* Able and willing to provide written informed consent before any study procedures.
Exclusion Criteria:
* 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/nitra…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Participants with AEs/SAEs
Timeframe: Day 1 (dosing) through Day 8
2
Blood pressure
Timeframe: Baseline through Day 8.
3
Pulse rate
Timeframe: Baseline through Day 8.
4
Respiratory rate
Timeframe: Baseline through Day 8.
5
Body temperature
Timeframe: Baseline through Day 8.
6
ECG heart rate
Timeframe: Baseline through Day 8.
7
ECG intervals
Timeframe: Baseline through Day 8.
8
Laboratory tests
Timeframe: Baseline through Day 8.
Trial details
NCT IDNCT07732387
SponsorYanping Kong
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2026-09-19
Contact for this trial
Clinical Research Coordinator at Nucleus Network Brisbane