56 Participants Needed

Viagra vs Hezkue for Erectile Dysfunction

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

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.
See 3 more

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.
See 28 more

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
2Treatment groups
Experimental Treatment
Group I: Arm 2 - Viagra and ASP-001Experimental Treatment2 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 ViagraExperimental Treatment2 Interventions
Participants receive 100 mg of ASP-001 followed by a 6 day washout before receiving 100 mg of Viagra

Find a Clinic Near You

Who Is Running the Clinical Trial?

Aspargo Labs, Inc

Lead Sponsor

Trials
2
Recruited
70+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security