A Phase 1 interventional study of Viaca and Sildenafil 50 mg in Erectile Dysfunctions and Healthy Volunteer, sponsored by Yanping Kong. Not yet recruiting at 1 site in Australia. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Yanping Kong · Phase 1, Interventional, and Basic science
Among 12 studies in Erectile Dysfunction with a site in Australia — 3 open to participants now, 4 under way, none of them phase 3. Erectile Dysfunction · Australia.
Among the 12 studies in Erectile Dysfunction with a site in Australia, this one is the 9th largest by planned enrollment, is one of 2 that started in 2026, is the only one in phase 1, and was the 12th registered.
701 studies on the registry are indexed under Erectile Dysfunction; 125 are open to participants now.
This study's planned enrollment of 30 is below the median of 70 across 551 interventional studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →3 of the 12 studies in Erectile Dysfunction with a site in Australia are open now, in 1 country. Each count lists the studies.
Of the 78 Erectile Dysfunction studies recruiting now, 31 (40%) set no upper age limit and 34 (44%) stop at 75 or younger; 2 take children under 18; 7 take healthy volunteers.
This study: 18 Years to 65 Years · male · healthy volunteers too.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 2 started in 2026.
Median enrollment 64 across the 12 interventional studies. Of the 7 that completed or were terminated, 4 (57%) have results posted.
9 of 12 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Yanping Kong as lead sponsor.
Yanping Kong has 1 study filed under Erectile Dysfunction — fewer than ten, so there is no comparison to draw.
1 of the studies in Erectile Dysfunction with a site in Australia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05574868Rigicon, Inc.Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis (ERASE ED) | 2027-08-01 |
Among the 12 studies in Erectile Dysfunction with a site in Australia, from their registry updates:
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.
Five cohorts of 6 healthy male participants each (n≈30). Viaca dose cohorts: Cohort 1 (25/0.25 mg), Cohort 2 (50/0.5 mg), Cohort 3 (75/0.75 mg). Active-comparator cohorts: Cohort 4 (sildenafil 50 mg) and Cohort 5 (cabergoline 0.5 mg). Cohort 1 runs first; after Safety Review Committee (SRC) review of safety/tolerability/PK through Day 3, Cohorts 2, 4 and 5 may proceed in parallel; Cohort 3 proceeds after SRC review of Cohort 2. Participants fast ≥8 h overnight before dosing and 2 h after. They are confined to a Phase 1 unit and discharged on Day 5 (Cohorts 1-3 and 5) or Day 2 (Cohort 4), with a follow-up visit on Day 8 (±1). Total participation \~33 days including screening. (V2.0 amendment removed the former optional high-dose Viaca cohort.)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single oral dose of Viaca (sildenafil 25 mg / cabergoline 0.25 mg; one low-dose tablet) in 6 healthy male participants.
Drug: Viaca
Single oral dose of Viaca (sildenafil 50 mg / cabergoline 0.5 mg; one high-dose tablet
Drug: Viaca
Single oral dose of Viaca (sildenafil 75 mg / cabergoline 0.75 mg; one low + one high tablet
Drug: Viaca
Single oral dose of sildenafil 50 mg (two 25 mg tablets).
Drug: Sildenafil 50 mg
Single oral dose of cabergoline 0.5 mg (one 0.5 mg tablet).
Drug: Cabergoline 0.5 MG
fixed-dose oral tablet of sildenafil + cabergoline (low-dose 25/0.25 mg; high-dose 50/0.5 mg). Single oral dose.
single oral dose
single 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).
Time frame: Day 1 (dosing) through Day 8
Blood pressure
Change from Baseline in systolic and diastolic blood pressure. Unit: mmHg.
Time frame: Baseline through Day 8.
Pulse rate
Change from Baseline in pulse rate. Unit: beats/min.
Time frame: Baseline through Day 8.
Respiratory rate
Change from Baseline in respiratory rate. Unit: breaths/min.
Time frame: Baseline through Day 8.
Body temperature
Change from Baseline in body temperature. Unit: °C.
Time frame: Baseline through Day 8.
ECG heart rate
Change from Baseline in 12-lead ECG heart rate. Unit: beats/min.
Time frame: Baseline through Day 8.
ECG intervals
Change from Baseline in 12-lead ECG intervals (QTcF, PR, QRS). Unit: milliseconds.
Time frame: Baseline through Day 8.
Laboratory tests
Number of participants with clinically significant safety laboratory abnormalities. Unit: participants.
Time frame: Baseline through Day 8.
Physical examination
Number of participants with clinically significant physical examination findings. Unit: participants.
Time frame: Baseline through Day 8.
Cmax
Maximum observed plasma concentration (Cmax). Unit: e.g. ng/mL.
Time frame: Predose (Day 1) through 168 hours post-dose (Day 8).
Tmax
Time to maximum plasma concentration (Tmax). Unit: hours.
Time frame: Predose (Day 1) through 168 hours post-dose (Day 8).
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.
Time frame: Predose (Day 1) through 168 hours post-dose (Day 8)
AUC0-24
AUC from time 0 to 24 hours (AUC0-24). Unit: e.g. ng·h/mL.
Time frame: Predose (Day 1) through 168 hours post-dose (Day 8).
AUC0-inf
AUC from time 0 extrapolated to infinity (AUC0-inf). Unit: e.g. ng·h/mL.
Time frame: Predose (Day 1) through 168 hours post-dose (Day 8).
%AUCextrap
Percentage of AUC0-inf obtained by extrapolation (%AUCextrap). Unit: percentage.
Time frame: Predose (Day 1) through 168 hours post-dose (Day 8).
t½
Apparent terminal elimination half-life (t½). Unit: hours.
Time frame: Predose (Day 1) through 168 hours post-dose (Day 8).
kel
Terminal elimination rate constant (kel). Unit: 1/hour.
Time frame: Predose (Day 1) through 168 hours post-dose (Day 8).
CL/F
Apparent total clearance after oral dosing (CL/F). Unit: e.g. L/h.
Time frame: Predose (Day 1) through 168 hours post-dose (Day 8).
Vz/F
Apparent volume of distribution during the terminal phase after oral dosing (Vz/F). Unit: e.g. L.
Time frame: Predose (Day 1) through 168 hours post-dose (Day 8).
Cmax/D
Dose-normalised maximum plasma concentration (Cmax/D). Unit: e.g. ng/mL per mg.
Time frame: Predose (Day 1) through 168 hours post-dose (Day 8).
AUC0-inf/D
Dose-normalised AUC0-inf (AUC0-inf/D). Unit: e.g. ng·h/mL per mg.
Time frame: Predose (Day 1) through 168 hours post-dose (Day 8).
AUC0-t/D
Dose-normalised AUC0-t (AUC0-t/D). Unit: e.g. ng·h/mL per mg.
Time frame: Predose (Day 1) through 168 hours post-dose (Day 8).
Dose proportionality
Dose proportionality of Cmax and AUC across Viaca dose levels. Unit: e.g. slope (power-model estimate).
Time frame: Predose (Day 1) through 168 hours post-dose (Day 8).
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Sep 2026, 1 month later.
Of 18 phase 1 interventional studies under Erectile Dysfunction, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 19. This study's planned 1 month is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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