56 Participants Needed

Viagra vs Hezkue for Erectile Dysfunction

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

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.
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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.
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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?
2Treatment groups
Experimental Treatment
Group I: Arm 2 - Viagra and ASP-001Experimental Treatment2 Interventions
Group II: Arm 1 - ASP-001 and ViagraExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Aspargo Labs, Inc

Lead Sponsor

Trials
2
Recruited
70+
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