Hezkue for Erectile Dysfunction

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Aspargo Labs, Inc

Must not be taking: Nitric oxide donors, Antihypertensives, PDE5 inhibitors

Disqualifiers: Renal, Hepatic, Cardiovascular, Psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how the body processes Hezkue® (sildenafil) for erectile dysfunction when taken with food versus on an empty stomach. Participants will receive the medication under both conditions to determine if eating affects the drug's effectiveness. Healthy men without major health problems, who can fast or eat specific meals as required, might be suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people.

Will I have to stop taking my current medications?

Yes, you will need to stop taking most medications, including prescription and non-prescription drugs, at least seven days before the study, unless the study team decides they won't interfere with the study. Some specific medications, like CYP enzyme inhibitors and inducers, need to be stopped 14 to 28 days before the study.

Is there any evidence suggesting that Hezkue® (ASP-001.1, Sildenafil) is likely to be safe for humans?

Research has shown that sildenafil, the main ingredient in Hezkue, has undergone extensive testing. Studies have found it to be generally well-tolerated in over 3,700 patients. Common side effects include headaches, skin redness, and upset stomach, which are usually mild. The FDA has already approved sildenafil for treating erectile dysfunction, indicating a strong safety record. Although this specific study is in its early stages, past research supports sildenafil's safety for adults. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Hezkue® (ASP-001.1) for erectile dysfunction because it offers a fresh approach by examining the effects of the drug under different dietary conditions. Unlike existing treatments like Viagra or Cialis, Hezkue® is being tested to see how food intake might influence its effectiveness, which could lead to more personalized treatment options. This investigation into the impact of fed versus fasted states is unique and could help optimize how and when the medication is best taken for maximum benefit.

What evidence suggests that Hezkue® (ASP-001.1, Sildenafil) might be an effective treatment for erectile dysfunction?

Research has shown that sildenafil, the main ingredient in Hezkue, effectively treats erectile dysfunction. Studies found that 82% of men using sildenafil achieved successful intercourse, with 77% succeeding consistently. This medication has a strong history of improving erectile function significantly more than a placebo. In this trial, participants will receive Hezkue under different conditions to evaluate its effectiveness. More frequent use of sildenafil has been linked to better sexual performance and a higher quality of life for men with erectile dysfunction. Overall, strong evidence supports sildenafil's effectiveness in treating this condition. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for healthy adult men who are interested in understanding how food affects the absorption and effectiveness of a new erectile dysfunction medication called Hezkue (sildenafil).

Inclusion Criteria

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

Participants must agree to practice an acceptable method of contraception as outlined in the protocol

My kidneys are functioning well, with a creatinine clearance over 80 mL/min.

Exclusion Criteria

Unwillingness or inability to follow the procedures specified by the protocol

Participant received any investigational drug/product within 30 days prior to the first dose

Presence of any clinically significant results from laboratory tests, vital signs assessments, and electrocardiograms

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive 100 mg of ASP-001.1 under either fed or fasted conditions based on randomization

1 day

1 visit (in-person)

Washout Period

A washout period between treatment periods to ensure no carryover effects

1-2 weeks

Treatment Period 2

Participants receive 100 mg of ASP-001.1 under the opposite condition (fed or fasted) from Treatment Period 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hezkue® (ASP-001.1, Sildenafil)

Trial Overview The study is testing whether eating before taking Hezkue (100 mg) changes its effects compared to taking it without food. This phase 1 trial will compare the two scenarios in participants.

How Is the Trial Designed?

Group I: Arm 2- Fed vs Fasted Conditions Experimental Treatment 1 Intervention

Participants receive 100mg of ASP-001.1 first under fed conditions and under fasted conditions after

Group II: Arm 1 - Fasted vs Fed Conditions Experimental Treatment 1 Intervention

Participants receive 100mg of ASP-001.1 first under fasted conditions and under fed conditions after

Who Is Running the Clinical Trial?

Aspargo Labs, Inc

Lead Sponsor

Trials

2

Recruited

70+

Published Research Related to This Trial

In a study of 3488 men with erectile dysfunction, 27.9% experienced tadalafil-associated adverse events (AEs), with diabetes, age, and geographic region being key factors influencing the likelihood of these AEs.

Specific patient characteristics, such as the use of antihypertensive medications and height, were linked to an increased risk of vasodilatory AEs, while no significant predictors were found for musculoskeletal or gastrointestinal AEs due to their low incidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Likelihood of tadalafil-associated adverse events in integrated multiclinical trial database: classification tree analysis in men with erectile dysfunction. Brock, G., Glina, S., Moncada, I., et al.[2015]

Sildenafil citrate is an effective and well-tolerated treatment for erectile dysfunction, evaluated in over 3700 patients across various studies, with a low discontinuation rate due to adverse events (2.5% for sildenafil vs. 2.3% for placebo).

The most common side effects were mild to moderate, including headache (16% for sildenafil), flushing (10%), and dyspepsia (7%), with no serious complications like priapism reported, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical safety of oral sildenafil citrate (VIAGRA) in the treatment of erectile dysfunction. Morales, A., Gingell, C., Collins, M., et al.[2022]

A large observational study involving 22,471 patients found that sildenafil, used primarily for erectile dysfunction, has a safety profile consistent with expectations, with no unexpected adverse drug reactions reported.

The study showed that the standardized mortality ratio for deaths due to ischemic heart disease in patients taking sildenafil was not higher than that of the general male population in England, indicating no increased risk associated with the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the safety of sildenafil for male erectile dysfunction: experience gained in general practice use in England in 1999. Boshier, A., Wilton, LV., Shakir, SA.[2015]

Citations

1. ctv.veeva.com ctv.veeva.com/study/study-to-compare-the-effects-of-viagra-r-vs-hezkue-r-in-healthy-fasted-male-participants

Study to Compare the Effects of Viagra® Vs Hezkue® in ... The study aims to demonstrate bioequivalence between the ASP-001 and Viagra formulations and to evaluate whether the absorption rate of ASP-001 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2699643/

Sildenafil in the treatment of erectile dysfunction: an overview ... Success with sildenafil, defined as 75% successful intercourse, was reported by 82% of patients with 77% being successful at every attempt (Guay et al 2001).

3. ichgcp.net ichgcp.net/clinical-trials-registry/548525-hezkue-hezkue-turbo-and-commercial-sildenafil-products-in-fed-healthy-male-subject

Comparing Sildenafil Formulations for Erectile Dysfunction Clinical trial comparing absorption of Hezkue sildenafil formulations versus commercial ED medications in healthy males, examining safety ...

4. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/211714

Sildenafil for Male Erectile Dysfunction: A Systematic ... Use of sildenafil produced a large and statistically significant improvement in erectile function compared with use of placebo. Treatment benefit was found for ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090429515002538

Association Between Dosage Frequency and the ... Higher dosage frequency of sildenafil is associated with a better improvement of sexual function and quality of life of men with ED, and the concomitant ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07117383

Hezkue®, Hezkue Turbo®, and Commercial Sildenafil ... The goal of this clinical trial is to compare how different sildenafil formulations are absorbed and tolerated in healthy adult males under fed conditions.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2387281/

Long-term safety and effectiveness of sildenafil citrate in ... The efficacy, safety, and tolerability of sildenafil in the treatment of men with ED have been demonstrated in numerous studies of 1-year duration or less.

8. accessdata.fda.gov accessdata.fda.gov/spl/data/1ab609f4-69d8-42a8-e063-6294a90a5060/1ab609f4-69d8-42a8-e063-6294a90a5060.xml

1ab609f4-69d8-42a8-e063-6294a90a5060.xml ... data on the safety or efficacy of sildenafil tablets in patients ... Sildenafil tablet is a prescription medicine used to treat erectile dysfunction (ED).

9. mayoclinic.org mayoclinic.org/drugs-supplements/sildenafil-oral-route/description/drg-20066989

Sildenafil (oral route) - Side effects & dosage Safety and efficacy have not been established. Sildenafil should never be used in children for erectile dysfunction. In general, sildenafil should not be ...

10. withpower.com withpower.com/trial/phase-1-erectile-dysfunction-2-2025-8fdbf

Hezkue for Erectile Dysfunction Sildenafil, used for erectile dysfunction, has been tested in over 3700 patients and is generally well-tolerated. Common side effects include headaches, ...