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Erectile DysfunctionPhase 1NCT07117383

Hezkue®, Hezkue Turbo®, and Commercial Sildenafil Products in Fed Healthy Male Subject

A Phase 1 study testing ASP-001.1, ASP-001 and Commercial Sildenafil and Sildenafil/Tadalafil Products in people with Erectile Dysfunction, run by Aspargo Labs, Inc at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to compare how different sildenafil formulations are absorbed and tolerated in healthy adult males under fed conditions. The main questions it aims to answer are: Do Hezkue and Hezkue Turbo differ in absorption compared to other commercial sildenafil products? Are there any… 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
Erectile Dysfunction
What is being tested?
ASP-001.1, ASP-001 and Commercial Sildenafil and Sildenafil/Tadalafil Products
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteUnited States
Study dates
Jan 2026to Mar 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

  • Participant must be informed of the nature of the study and voluntarily agree to participate by signing an informed consent form prior to any study-specific procedures.
  • Participant must be a healthy male, aged 18 to 70 years (inclusive) at the time of dosing.
  • Participant must be judged by the Investigator or designee to be in good general health, as documented by medical history, physical examination, clinical laboratory tests, vital signs, and 12-lead electrocardiogram (ECG). Any deviations from normal ranges must be assessed and deemed not clinically significant by the Investigator or designee.
  • Participant must have a creatinine clearance (CrCl) value greater than 80 mL/min, as calculated by the Cockcroft-Gault equation.
  • Participant must agree to practice an acceptable method of contraception throughout the clinical trial, as outlined in the protocol.

Who cannot join

  • Unwilling or unable to comply with study procedures.
  • Use of any investigational drug (except Hezkue/Hezkue Turbo) within 30 days prior to dosing.
  • History of significant renal, hepatic, cardiovascular (including orthostatic hypotension), psychiatric, neoplastic, infectious disease, or diabetes mellitus.
  • Clinically significant abnormal lab results, vital signs, or ECGs.
  • Any hepatic impairment or abnormal liver function tests.
  • Positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
Show all 33Show fewer
  • Clinically significant illness within 28 days prior to dosing.
  • Known hypersensitivity to sildenafil, tadalafil, vardenafil, or any component of the investigational product (e.g., peppermint oil).
  • History of significant food or drug allergies.
  • History of drug abuse within the past year or positive drug screen at screening.
  • Regular alcohol consumption exceeding 15 units per week.
  • Use of CYP450 enzyme inhibitors within 14 days prior to dosing.
  • Use of CYP450 enzyme inducers or St. John's Wort within 28 days prior to dosing.
  • Blood donation or significant blood loss within 3 months before screening.
  • Plasma donation within 14 days prior to first dose.
  • Inadequate venous access for repeated blood sampling.
  • Difficulty fasting or inability to consume standardized meals.
  • Intolerance to fatty foods or inability to consume a high-fat, high-calorie breakfast.
  • Difficulty swallowing.
  • Regular use of tobacco or nicotine products within 4 weeks prior to screening.
  • Major surgery within 3 months or minor surgery within 1 month before screening.
  • Considered unsuitable for study participation by the Investigator.
  • Institutionalized status.
  • Use of hormone replacement therapy within 6 months prior to dosing.
  • Consumption of Seville oranges, grapefruit, or pomelo within 7 days prior to dosing.
  • Consumption of caffeine, xanthine-containing products, or poppy seeds within 48 hours prior to dosing.
  • Receipt of a COVID-19 vaccine within 3 days prior to dosing.
  • Presence of braces, retainers, dentures, partial dentures, or tongue piercings.
  • Use of nitric oxide donors, organic nitrates/nitrites, antihypertensive medications, or PDE5 inhibitors within 14 days of dosing.
  • Blood pressure or heart rate outside acceptable ranges:
  • Systolic BP <90 or >140 mmHg
  • Diastolic BP <50 or >90 mmHg
  • Heart rate <50 or >100 bpm

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Aspargo Labs

    New York, New York, 10004

    Mario Guralnik, PhD, 714-818-3000, mguralnik@aspargolabs.com

Other trials in United States

About this study

Official title: A Phase 1 Pharmacokinetic Study Comparing Hezkue® (ASP-001), Hezkue Turbo® (ASP-001.1), and Select Commercially Available Sildenafil Products Under Fed Conditions in Healthy Adult Male Subjects

The goal of this clinical trial is to compare how different sildenafil formulations are absorbed and tolerated in healthy adult males under fed conditions. The main questions it aims to answer are:

Do Hezkue and Hezkue Turbo differ in absorption compared to other commercial sildenafil products?

Are there any differences in safety or tolerability between the products?

Researchers will compare multiple formulations to evaluate differences in drug absorption and side effects.

Read the detailed description

The goal of this clinical trial is to learn how different formulations of sildenafil-used to treat erectile dysfunction-are absorbed in the body when taken with food, and to understand how safe and well-tolerated they are in healthy adult males. The main questions it aims to answer are:

How do the blood levels of sildenafil compare between Hezkue, Hezkue Turbo, and other commercial sildenafil products?

Do differences in formulation (such as particle size or combination with tadalafil) affect the absorption or safety profile?

Researchers will compare Hezkue and Hezkue Turbo to other sildenafil-containing products (such as Pfizer Viagra, BlueChew, and Ro Sparks) to see if there are differences in how quickly and how much of the drug enters the bloodstream.

Participants will:

  • Take a single oral dose of one of the test products after eating a high-fat meal.
  • Have blood samples taken over a 4-hour period to measure drug levels.
  • Be monitored for side effects and overall health for up to 4 days after each dose.
  • Have the option to return for additional visits to test other products, with a 4-day break in between.
Being tested
ASP-001.1, ASP-001, Commercial Sildenafil and Sildenafil/Tadalafil Products
Keywords
erectile dysfunction, Viagra, sildenafil, tadalafil
Medical subject headings
Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASP-001.1Device

    Also called Hezkue®, sildenafil citrate oral suspension, sildenafil

    Bottle/pump containing ASP-001.1 suspension

  • ASP-001Drug

    Also called Hezkue Turbo®, sildenafil citrate oral suspension, sildenafil

    Oral liquid suspension of sildenafil

  • Commercial Sildenafil and Sildenafil/Tadalafil ProductsDrug

    Also called Viagra®, Galotam, BlueChew, Aristo Sildaristo, Lemonaid Viagra, Ro Sparks, Hims Hard Mints, Hello Cake ED Cake Meds

    A selection of marketed sildenafil or sildenafil + tadalafil products used as comparators. Includes tablets and chewables such as Viagra®, Galotam, BlueChew, Aristo Sildaristo, Lemonaid Viagra, Ro Sparks, Hims Hard Mints, and Hello Cake ED Cake Meds.

Study groups in NCT07117383
Study groupRoleWhat they receive
Hezkue FormulationsExperimentalParticipants in this arm receive a single dose of 100mg (miligrams) of either Hezkue® (ASP-001) or Hezkue Turbo® (ASP-001.1), both liquid formulations containing sildenafil citrate.
Receives: Device: ASP-001.1; Drug: ASP-001
Commercially Available Sildenafil ProductsExperimentalParticipants in this arm receive a single dose of one of several comparator products, including commercially available sildenafil tablets or sildenafil + tadalafil combination chewables.
Receives: Drug: Commercial Sildenafil and Sildenafil/Tadalafil Products

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tmax - Time to Maximum Observed Plasma Concentration of Sildenafil

    Measurement of the time (Tmax) to reach maximum observed plasma concentration of sildenafil following a single oral dose under fed conditions.

    Measured: Baseline and up to 4 hours post-dose at 23 specified timepoints

  2. Cmax - Maximum Observed Plasma Concentration of Sildenafil

    Measurement of the maximum observed plasma concentration (Cmax) of sildenafil following a single oral dose of study drug.

    Measured: Baseline and at 23 timepoints within 4 hours post-dose.

Secondary outcomes (2)

  1. Number of Participants Reporting Oral Irritation, Dizziness, or Headache

    To assess the frequency and severity of oral irritation, dizziness, or headache following administration of ASP-001.1 (Hezkue Turbo). Descriptive summaries (mean, standard deviation, median, minimum, and maximum) of actual values and changes from baseline will be provided.

    Measured: From pre-dose through 96 hours post-dose.

  2. Number of Participants With Adverse Events

    The frequency and type of adverse events reported during the study will be summarized, including severity and relationship to study drug.

    Measured: From pre-dose through 96 hours post-dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2025
  2. Study startJan 2026 (estimated)
  3. Primary completionMar 2026 (estimated)
  4. Study completionMar 2026 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07117383
Sponsor's protocol ID
ASP-012-SIL
Status last verified
Aug 2025
First submitted
5 Aug 2025
Last updated
12 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No: Individual participant data will not be shared because this study is an early-phase pharmacokinetic trial with a small sample size and limited potential for secondary analyses.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ASP-001.1, ASP-001 and Commercial Sildenafil and Sildenafil/Tadalafil Products in people with Erectile Dysfunction, run by Aspargo Labs, Inc at 1 site in United States.

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 5 inclusion and 33 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 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tmax - Time to Maximum Observed Plasma Concentration of Sildenafil (time frame: Baseline and up to 4 hours post-dose at 23 specified timepoints). 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?

On the ClinicalTrials.gov record for NCT07117383.

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 12 Dec 2025.

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