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

Trial Summary

What is the purpose of this trial?

The objective of this phase 1 study is to evaluate the food effect of 100 mg Hezkue Turbo® (ASP-001.1, sildenafil) under fed versus 100 mg of Hezkue Turbo® (ASP-001.1, sildenafil) under fasted conditions in healthy adult male subjects

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.

What data supports the effectiveness of the drug Hezkue® (ASP-001.1, Sildenafil) for erectile dysfunction?

Research shows that sildenafil, the active ingredient in Hezkue®, is effective in treating erectile dysfunction. Studies indicate that sildenafil improves erectile function and increases treatment satisfaction, especially when combined with personalized instructions and dose adjustments. ^{1 2 3 4 5}

Is sildenafil (Hezkue) safe for humans?

Sildenafil, used for erectile dysfunction, has been tested in over 3700 patients and is generally well-tolerated. Common side effects include headaches, flushing, and indigestion, which are usually mild. Serious side effects are rare, and most people can use it safely. ^{6 7 8 9 10}

What makes the drug Hezkue® (ASP-001.1, Sildenafil) unique for treating erectile dysfunction?

Hezkue® (ASP-001.1, Sildenafil) is unique because it is a form of sildenafil, a well-known PDE-5 inhibitor, which has a large evidence base for efficacy and safety in treating erectile dysfunction. It may offer an alternative administration route, such as orodispersible films that dissolve quickly in the mouth, potentially improving patient satisfaction and adherence. ^{4 9 11 12 13}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The PsychoedPlusMed approach to erectile dysfunction treatment: the impact of combining a psychoeducational intervention with sildenafil. [2015]

2. England pubmed.ncbi.nlm.nih.gov

The treatment of erectile dysfunction study: focus on treatment satisfaction of patients and partners. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

A prospective study of the beneficial effects of dose optimization and customized instructions on patient satisfaction with sildenafil citrate (Viagra) for erectile dysfunction. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Use of medications for erectile dysfunction in the United States, 1996 through 2001. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Sildenafil citrate (Viagra) treatment for erectile dysfunction: An updated profile of response and effectiveness. [2015]

6. England 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. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Likelihood of tadalafil-associated adverse events in integrated multiclinical trial database: classification tree analysis in men with erectile dysfunction. [2015]

8. England pubmed.ncbi.nlm.nih.gov

Clinical safety of oral sildenafil citrate (VIAGRA) in the treatment of erectile dysfunction. [2022]

9. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[PDE-5 inhibitors: patients preferences]. [2017]

10. England pubmed.ncbi.nlm.nih.gov

A real-world pharmacovigilance study of FDA adverse event reporting system events for sildenafil. [2023]

11. Spain pubmed.ncbi.nlm.nih.gov

Safety and efficacy of intraurethral alprostadil in patients with erectile dysfunction refractory to treatment using phosphodiesterase-5 inhibitors. [2017]

12. England pubmed.ncbi.nlm.nih.gov

Data on the utilization of treatment modalities for ED in Taiwan in the era of PDE5 inhibitors. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Prescribing patterns and costs associated with erectile dysfunction drugs in England: a time trend analysis. [2021]