Healthy VolunteersPhase 1NCT07302698
PK and Onset of Hezkue Oral Sildenafil Suspension After Alcohol Consumption
A Phase 1 study testing Hezkue Oral Sildenafil Suspension in people with Healthy Volunteers, run by Aspargo Labs, Inc.
Trial summary
This is an open-label, randomized study evaluating the pharmacokinetics and onset performance of Hezkue® oral sildenafil suspension administered following moderate alcohol consumption in healthy adult subjects. Participants will receive Hezkue® under controlled alcohol-exposure conditions. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Hezkue Oral Sildenafil Suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2026to 28 May 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female adults 21 to 55 years of age, inclusive.
- Body mass index (BMI) between 18.0 and 30.0 kg/m², inclusive.
- Medically healthy based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations, in the opinion of the investigator.
- Able to safely consume moderate amounts of alcohol as judged by the investigator (for example, no history of alcohol intolerance, alcohol use disorder, or alcohol-related medical complications).
- Blood pressure and heart rate within normal or non-clinically significant ranges at screening and baseline, in the opinion of the investigator.
- Non-smoker or light smoker (10 cigarettes per day or fewer, or equivalent) willing to abstain during study confinement periods.
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- Able to understand and provide written informed consent before any study-specific procedures are performed.
- Willing and able to comply with all study requirements, including alcohol restrictions, fasting, dosing schedules, and pharmacokinetic and onset assessments.
- Females of childbearing potential must use acceptable contraception as determined by the investigator.
Who cannot join
- History or presence of any clinically significant cardiovascular disease, including but not limited to coronary artery disease, heart failure, clinically important arrhythmias, or uncontrolled hypertension or hypotension.
- Resting systolic blood pressure or diastolic blood pressure, or heart rate, outside protocol-defined acceptable ranges at screening or baseline, in the opinion of the investigator.
- Known hypersensitivity or contraindication to sildenafil, other phosphodiesterase type 5 (PDE5) inhibitors, alcohol, or any component of the study formulations.
- Current or recent use of nitrates, nitric oxide donors, or guanylate cyclase stimulators (for example, riociguat).
- History of significant hepatic, renal, gastrointestinal, neurologic, psychiatric, endocrine, hematologic, or respiratory disease that, in the investigator's opinion, could interfere with study participation or data interpretation.
- History of syncope, significant orthostatic hypotension, or other conditions that may be worsened by sildenafil or alcohol.
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- History of alcohol use disorder, binge drinking patterns, or other substance use disorder, as determined by the investigator.
- Positive urine drug screen or positive alcohol test at screening (outside scheduled alcohol administration for the study) or at admission.
- Use of prescription or over-the-counter medications, herbal products, or dietary supplements within 14 days before the first study dose, unless considered acceptable by the investigator.
- Positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV.
- Participation in another clinical study or receipt of an investigational drug or device within 30 days or 5 half-lives (whichever is longer) before the first study dose.
- Donation of 450 mL or more of blood, or significant blood loss, within 8 weeks before the first study dose.
- Pregnant or breastfeeding females.
- Women of childbearing potential not using acceptable contraception.
- Any condition or circumstance that, in the opinion of the investigator, would make the participant unsuitable for the study or could interfere with compliance or study assessments.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Pharmacokinetics and Onset Performance of Hezkue® Oral Sildenafil Suspension Following Alcohol Consumption in Healthy Adults
This is an open-label, randomized study evaluating the pharmacokinetics and onset performance of Hezkue® oral sildenafil suspension administered following moderate alcohol consumption in healthy adult subjects. Participants will receive Hezkue® under controlled alcohol-exposure conditions. Pharmacokinetic sampling, onset assessments, and safety evaluations will be conducted throughout the study.
- Conditions
- Healthy Volunteers
- Being tested
- Hezkue Oral Sildenafil Suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hezkue Oral Sildenafil SuspensionDrug
Hezkue® oral sildenafil suspension will be administered as a single oral dose following controlled moderate alcohol consumption under fasting or standardized conditions, according to the study schedule, to evaluate pharmacokinetics, onset performance, and safety.
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm Crossover | Experimental | Not described Receives: Drug: Hezkue Oral Sildenafil Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC₀-t) of Sildenafil
Measured: From predose up to approximately 24 hours postdose in each study period
Maximum Observed Plasma Concentration (Cmax) of Sildenafil
Measured: From predose up to approximately 24 hours postdose in each study period
Time to Onset of Effect as Assessed by Participant-Reported Onset
Measured: From dosing up to approximately 4 hours postdose in each study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start15 Mar 2026 (estimated)
- Primary completion15 May 2026 (estimated)
- Study completion28 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Aspargo Labs, IncThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aspargo Labs, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302698
- Sponsor's protocol ID
- ASP-021-Sil
- Status last verified
- Nov 2025
- First submitted
- 11 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Pharmacokinetics and Onset Performance of Hezkue® Oral Sildenafil Suspension Following Alcohol Consumption in Healthy Adults
- ClinicalTrials.gov ID
- NCT07302698
- Acronym / sponsor ID
- ASP-021-Sil
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Aspargo Labs, IncIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 28 May 2026 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, randomized study evaluating the pharmacokinetics and onset performance of Hezkue® oral sildenafil suspension administered following moderate alcohol consumption in healthy adult subjects. Participants will receive Hezkue® under controlled alcohol-exposure conditions. Pharmacokinetic sampling, onset assessments, and safety evaluations will be conducted throughout the study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Arm Crossover | Experimental | Drug: Hezkue Oral Sildenafil Suspension |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female adults 21 to 55 years of age, inclusive.
- Body mass index (BMI) between 18.0 and 30.0 kg/m², inclusive.
- Medically healthy based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations, in the opinion of the investigator.
- Able to safely consume moderate amounts of alcohol as judged by the investigator (for example, no history of alcohol intolerance, alcohol use disorder, or alcohol-related medical complications).
- Blood pressure and heart rate within normal or non-clinically significant ranges at screening and baseline, in the opinion of the investigator.
Key exclusion criteria (15 listed)
- History or presence of any clinically significant cardiovascular disease, including but not limited to coronary artery disease, heart failure, clinically important arrhythmias, or uncontrolled hypertension or hypotension.
- Resting systolic blood pressure or diastolic blood pressure, or heart rate, outside protocol-defined acceptable ranges at screening or baseline, in the opinion of the investigator.
- Known hypersensitivity or contraindication to sildenafil, other phosphodiesterase type 5 (PDE5) inhibitors, alcohol, or any component of the study formulations.
- Current or recent use of nitrates, nitric oxide donors, or guanylate cyclase stimulators (for example, riociguat).
- History of significant hepatic, renal, gastrointestinal, neurologic, psychiatric, endocrine, hematologic, or respiratory disease that, in the investigator's opinion, could interfere with study participation or data interpretation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hezkue Oral Sildenafil SuspensionHezkue® oral sildenafil suspension will be administered as a single oral dose following controlled moderate alcohol consumption under fasting or standardized conditions, according to the study schedule, to evaluate pharmacokinetics, onset performance, and safety. | Drug | Single-Arm Crossover |
Primary outcome
Area Under the Plasma Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC₀-t) of Sildenafil
Time frame: From predose up to approximately 24 hours postdose in each study period
Maximum Observed Plasma Concentration (Cmax) of Sildenafil
Time frame: From predose up to approximately 24 hours postdose in each study period
Time to Onset of Effect as Assessed by Participant-Reported Onset
Time frame: From dosing up to approximately 4 hours postdose in each study period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hezkue Oral Sildenafil Suspension in people with Healthy Volunteers, run by Aspargo Labs, Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Avi Guralnik (17189381157, avi.berg@synergy-cro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Plasma Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC₀-t) of Sildenafil (time frame: From predose up to approximately 24 hours postdose in each study period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.