Erectile DysfunctionPhase 2NCT07290400
Effect of Moderate Alcohol on Absorption and Onset of Hezkue Sildenafil Suspension
A Phase 2 study testing Hezkue Sildenafil Oral Suspension and Moderate Alcohol Intake in people with Erectile Dysfunction, run by Aspargo Labs, Inc.
Trial summary
This is a Phase 2, open-label, randomized crossover study assessing the effect of moderate alcohol intake on the absorption and onset of action of Hezkue® sildenafil oral suspension in adult subjects. Participants will receive Hezkue® under different alcohol intake conditions in randomized sequence. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Hezkue Sildenafil Oral Suspension and Moderate Alcohol Intake
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2026to 28 Jun 2026
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male adults 21 to 65 years of age, inclusive
- Documented history of erectile dysfunction for at least 6 months, as determined by the investigator
- In a stable sexual relationship and willing to attempt sexual activity as required by study procedures, if applicable
- Medically stable based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations, in the opinion of the investigator
- Able, in the investigator's judgment, to safely consume moderate amounts of alcohol as defined in the protocol
- Willing to abstain from alcohol outside of protocol-specified intake during the study
- Able to understand and provide written informed consent before any study-specific procedures are performed
- Willing and able to comply with all study procedures, including dosing, washout periods, pharmacokinetic sampling, onset assessments, and safety monitoring
Who cannot join
- Known hypersensitivity or contraindication to sildenafil, other PDE5 inhibitors, alcohol, or any component of the Hezkue® formulation
- Use of nitrates, nitric oxide donors, guanylate cyclase stimulators (such as riociguat), or other prohibited medications within a protocol-defined period
- Clinically significant cardiovascular disease, including coronary artery disease, heart failure, clinically important arrhythmias, recent stroke, or uncontrolled hypertension or hypotension
- Resting blood pressure or heart rate outside protocol-defined acceptable ranges at screening or baseline, in the opinion of the investigator
- Significant hepatic, renal, neurologic, psychiatric, endocrine, hematologic, or respiratory disease that could increase risk or interfere with study assessments
- History of syncope, significant orthostatic hypotension, or other conditions that may be worsened by sildenafil or alcohol
Show all 13Show fewer
- History of alcohol use disorder, binge drinking, or other substance use disorder, as determined by the investigator
- Positive urine drug screen or positive alcohol test at screening or admission (outside protocol-specified alcohol administration)
- Use of prescription or over-the-counter medications, herbal products, or dietary supplements within 14 days before first dosing unless approved 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 product within 30 days or 5 half-lives, whichever is longer
- Donation of 450 mL or more of blood, or significant blood loss, within 8 weeks before first dosing
- Any condition or circumstance that, in the opinion of the investigator, would make the participant unsuitable or interfere with study conduct or interpretation
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: Phase 2 Crossover Study Assessing the Effect of Moderate Alcohol Intake on the Absorption and Onset of Action of Hezkue® Sildenafil Oral Suspension
This is a Phase 2, open-label, randomized crossover study assessing the effect of moderate alcohol intake on the absorption and onset of action of Hezkue® sildenafil oral suspension in adult subjects. Participants will receive Hezkue® under different alcohol intake conditions in randomized sequence. Pharmacokinetic sampling and onset assessments will be performed after each administration, and safety will be monitored throughout the study.
- Conditions
- Erectile Dysfunction
- Being tested
- Hezkue Sildenafil Oral Suspension, Moderate Alcohol Intake
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hezkue Sildenafil Oral SuspensionDrug
Hezkue® sildenafil oral suspension will be administered as a single oral dose in each study period under different alcohol intake conditions (such as with and without moderate alcohol consumption), according to the randomized crossover design. Pharmacokinetic, absorption, onset of action, and safety parameters will be assessed after each administration.
Moderate Alcohol IntakeOther
A standardized moderate amount of alcohol will be administered under controlled conditions prior to dosing with Hezkue® sildenafil oral suspension in designated study periods, according to the protocol-defined alcohol intake procedures.
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm Crossover | Experimental | Not described Receives: Drug: Hezkue Sildenafil Oral Suspension |
| Hezkue® With Moderate Alcohol Intake | Experimental | Participants will receive Hezkue® sildenafil oral suspension administered following standardized moderate alcohol intake in one study period. Pharmacokinetic, absorption, onset of action, and safety assessments will be conducted following dosing. Receives: Drug: Hezkue Sildenafil Oral Suspension; Other: Moderate Alcohol Intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Onset of Effect as Assessed by Participant-Reported Erectile Response
Measured: From dosing up to approximately 4 hours postdose in each study period
Area Under the Plasma Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC₀-t) of Sildenafi
Measured: From predose up to approximately 24 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 posted18 Dec 2025
- Study start15 Apr 2026 (estimated)
- Primary completion15 Jun 2026 (estimated)
- Study completion28 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT07290400
- Sponsor's protocol ID
- ASP-022-Sil
- Status last verified
- Nov 2025
- First submitted
- 11 Dec 2025
- Last updated
- 18 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 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Crossover Study Assessing the Effect of Moderate Alcohol Intake on the Absorption and Onset of Action of Hezkue® Sildenafil Oral Suspension
- ClinicalTrials.gov ID
- NCT07290400
- Acronym / sponsor ID
- ASP-022-Sil
- Conditions
- Erectile Dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Aspargo Labs, IncIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 28 Jun 2026 (estimated)
- First posted
- 18 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 a Phase 2, open-label, randomized crossover study assessing the effect of moderate alcohol intake on the absorption and onset of action of Hezkue® sildenafil oral suspension in adult subjects. Participants will receive Hezkue® under different alcohol intake conditions in randomized sequence. Pharmacokinetic sampling and onset assessments will be performed after each administration, and safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-Arm Crossover | Experimental | Drug: Hezkue Sildenafil Oral Suspension |
| Hezkue® With Moderate Alcohol Intake | Experimental | Drug: Hezkue Sildenafil Oral Suspension, Other: Moderate Alcohol IntakeParticipants will receive Hezkue® sildenafil oral suspension administered following standardized moderate alcohol intake in one study period. Pharmacokinetic, absorption, onset of action, and safety assessments will be conducted following dosing. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male adults 21 to 65 years of age, inclusive
- Documented history of erectile dysfunction for at least 6 months, as determined by the investigator
- In a stable sexual relationship and willing to attempt sexual activity as required by study procedures, if applicable
- Medically stable based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations, in the opinion of the investigator
- Able, in the investigator's judgment, to safely consume moderate amounts of alcohol as defined in the protocol
Key exclusion criteria (13 listed)
- Known hypersensitivity or contraindication to sildenafil, other PDE5 inhibitors, alcohol, or any component of the Hezkue® formulation
- Use of nitrates, nitric oxide donors, guanylate cyclase stimulators (such as riociguat), or other prohibited medications within a protocol-defined period
- Clinically significant cardiovascular disease, including coronary artery disease, heart failure, clinically important arrhythmias, recent stroke, or uncontrolled hypertension or hypotension
- Resting blood pressure or heart rate outside protocol-defined acceptable ranges at screening or baseline, in the opinion of the investigator
- Significant hepatic, renal, neurologic, psychiatric, endocrine, hematologic, or respiratory disease that could increase risk or interfere with study assessments
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 Sildenafil Oral SuspensionHezkue® sildenafil oral suspension will be administered as a single oral dose in each study period under different alcohol intake conditions (such as with and without moderate alcohol consumption), according to the randomized crossover design. Pharmacokinetic, absorption, onset of action, and safety parameters will be assessed after each administration. | Drug | Hezkue® With Moderate Alcohol Intake, Single-Arm Crossover |
| Moderate Alcohol IntakeA standardized moderate amount of alcohol will be administered under controlled conditions prior to dosing with Hezkue® sildenafil oral suspension in designated study periods, according to the protocol-defined alcohol intake procedures. | Other | Hezkue® With Moderate Alcohol Intake |
Primary outcome
Time to Onset of Effect as Assessed by Participant-Reported Erectile Response
Time frame: From dosing up to approximately 4 hours postdose in each study period
Area Under the Plasma Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC₀-t) of Sildenafi
Time frame: From predose up to approximately 24 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 18 Dec 2025.
- Individual participant dataSharing planned: No
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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 2 study testing Hezkue Sildenafil Oral Suspension and Moderate Alcohol Intake in people with Erectile Dysfunction, 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 8 inclusion and 13 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 18 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Time to Onset of Effect as Assessed by Participant-Reported Erectile Response (time frame: From dosing up to approximately 4 hours postdose in each study period). The study lists 2 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 18 Dec 2025.