Starting soon
Phase 1
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Viaca (Sildenafil + Cabergoline) Compared With Sildenafil and Cabergoline
Condition(s) studied
Erectile DysfunctionsHealthy Volunteer
Investigational drug(s) / intervention(s)
Viaca: fixed-dose oral tablet of sildenafil + cabergoline (low-dose 25/0.25 mg; high-dose 50/0.5 mg). Single oral dose.
Sildenafil 50 mg: single oral dose
Cabergoline 0.5 MG: single oral dose
Study 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.
Eligibility
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/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.
* Fever (\>38°C) or symptomatic viral/bacterial infection within 2 weeks prior to Screening.
* Infections requiring parenteral antibiotics within 1 month prior to Screening.
* Concomitant use of an indwelling urethral catheter.
* Concomitant nitrates/nitric-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.
* Medications that significantly affect BP: nitrates (any form), alpha-blockers (e.g. doxazosin, terazosin, tamsulosin), guanylate cyclase stimulators (e.g. riociguat).
* Positive HCV antibody, HBsAg, or HIV antibody.
* Live vaccine within 4 weeks prior to first IP dose.
* Poor pill-swallowing ability or poor venous access.
* History of severe allergic/anaphylactic reactions or sensitivity to IP or constituents.
* History of malignancy (except non-melanoma skin cancer excised \>5 years prior to Screening).
* Clinically significant abnormal Screening ECG (e.g. QRS ≥ 120 msec and/or QTcF \> 450 msec, per Investigator).
* History/evidence of renal disease or eGFR \< 60 mL/min/1.73 m² at Screening (2021 CKD-EPI creatinine equation).
* Immunosuppressive drug exposure (incl. experimental therapies) within 4 months or 5 half-lives (whichever longer) prior to Screening.
* Positive urine toxicology panel (barbiturates, THC, amphetamines/methamphetamines, methadone, MDMA, phencyclidine, tricyclic antidepressants, benzodiazepines, opiates, cocaine) or positive alcohol breath test.
* Unwilling to abstain from alcohol, caffeine and nicotine from 48 h prior to admission, during confinement, and 48 h prior to follow-up visits.
* History of substance abuse/dependency or recreational IV drug use in the last 12 months (self-declared).
* Unwilling to refrain from strenuous exercise (incl. weightlifting) 48 h prior to admission and follow-up visits.
* Anything the Investigator considers would jeopardize participant safety, prevent full participation, or compromise data interpretation.
Primary outcome measure(s)
- Participants with AEs/SAEs — Day 1 (dosing) through Day 8
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). Unit: participants (summarised by severity and relatedness).
- Blood pressure — Baseline through Day 8.
Change from Baseline in systolic and diastolic blood pressure. Unit: mmHg.
- Pulse rate — Baseline through Day 8.
Change from Baseline in pulse rate. Unit: beats/min.
- Respiratory rate — Baseline through Day 8.
Change from Baseline in respiratory rate. Unit: breaths/min.
- Body temperature — Baseline through Day 8.
Change from Baseline in body temperature. Unit: °C.
- ECG heart rate — Baseline through Day 8.
Change from Baseline in 12-lead ECG heart rate. Unit: beats/min.
- ECG intervals — Baseline through Day 8.
Change from Baseline in 12-lead ECG intervals (QTcF, PR, QRS). Unit: milliseconds.
- Laboratory tests — Baseline through Day 8.
Number of participants with clinically significant safety laboratory abnormalities. Unit: participants.
- Physical examination — Baseline through Day 8.
Number of participants with clinically significant physical examination findings. Unit: participants.
Trial sites (1)
| Facility | City | Region | Status |
| Nucleus Network Brisbane |
Herston |
Queensland |
|
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