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

What You Need to Know Before You Apply

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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+