Viagra vs Hezkue for Erectile Dysfunction

Age: 18 - 65

Sex: Male

Trial Phase: Phase 1

Sponsor: Aspargo Labs, Inc

Must not be taking: 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

56 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this phase 1, open-label, single-center, two-way crossover trial is to evaluate the pharmacokinetics (PK), safety, and tolerability of 100 mg ASP-001 oral liquid suspension versus 100 mg Viagra (sildenafil citrate) tablets in fasted, healthy male volunteers

Eligibility Criteria

This trial is for healthy, fasted male participants who want to help compare the effects of two erectile dysfunction treatments: Viagra and a new drug called Hezkue (ASP-001).

Inclusion Criteria

The 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

I am a healthy man aged between 18 and 55.

My kidney function, measured by creatinine clearance, is good.

Exclusion Criteria

I have not used CYP enzyme inducers or St. John's Wort in the last 28 days.

Ingestion of any beverages containing more than 5% fruit juice (fruit drinks, fruit punches, fruit cocktails, fruit-ades, or other products containing 5% or less of fruit juice will be allowed) within 48 hours prior to first dose and for the duration of the study

I received a COVID-19 vaccine within three days before each visit.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period I

Participants receive either 100 mg of ASP-001 or 100 mg of Viagra

1 day

1 visit (in-person)

Washout

A washout period between treatment periods

6 days

Treatment Period II

Participants receive the alternate treatment (100 mg of ASP-001 or 100 mg of Viagra)

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

• ASP-001
• Viagra

Trial Overview The study is testing how the body processes a liquid form of ASP-001 compared to Viagra tablets. It's an open-label, phase 1 trial where each participant will try both treatments at different times.

Participant Groups

Group I: Arm 2 - Viagra and ASP-001 Experimental Treatment 2 Interventions

Participants receive 100 mg of Viagra followed by a 6 day washout before receiving 100 mg of ASP-001

Group II: Arm 1 - ASP-001 and Viagra Experimental Treatment 2 Interventions

Participants receive 100 mg of ASP-001 followed by a 6 day washout before receiving 100 mg of Viagra

Who Is Running the Clinical Trial?

Aspargo Labs, Inc

Lead Sponsor

Trials

2

Recruited

70+