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Comparing Viagra and ASP-001 in Healthy Men

This study is comparing two forms of sildenafil: a new liquid suspension called ASP-001 and the familiar Viagra tablet. It's for healthy men aged 18 to 55. Researchers want to see how quickly and how much of each medicine gets into your body (pharmacokinetics) and if they are absorbed similarly. They also want to check for any side effects. This study is currently unclear on its recruitment status, but plans to enroll at least 56 participants. Success for this study means showing that ASP-001 is absorbed similarly to Viagra and is well-tolerated.

Study design
This is a Phase 1, open-label study where 56 healthy men will receive both ASP-001 and Viagra at different times.
What's involved
Participants will take ASP-001 and Viagra, with a 6-day break between treatments. Blood samples will be taken at many times over 24 hours after each dose.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 hours after each dose to measure how the drugs are absorbed.

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NCT06782659

Study to Compare the Effects of Viagra® Vs Hezkue® in Healthy Fasted Male Participants.

Not Yet Recruiting
PHASE1Ages 18–55InterventionalTreatment
Aspargo Labs, Inc
~56 participants
Updated 2025-01-20 on ClinicalTrials.gov
What's tested:ASP-001Viagra

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cmax
Measured over Baseline and at 24 different timepoints during the 24 hour post-dose
+6 more outcomes measured

Conditions

Erectile Dysfunction

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Erectile Dysfunction

Where it's being run

2 sites across 1 states
Florida2

Who to contact

Cheryl Duggan
[email protected]
305-817-2900
Email the study team

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Eligibility criteria

Inclusion

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.
Participants must be healthy male volunteers aged 18 to 55 years (inclusive) at the time of dosing.
Participants must have a body mass index between 18.0 and 29.9 kg/m² (inclusive) and a body weight of 50 to 100 kg (inclusive).
Participants must be judged by the Investigator or designee to be in good general health, as documented by medical history, physical examination, clinical laboratory tests, vital signs, and 12-lead electrocardiogram (ECG). Any deviations from normal ranges must be assessed and deemed not clinically significant by the Investigator or designee.
Participants must have a creatinine clearance (CrCl) value greater than 80 mL/min, as calculated by the Cockcroft-Gault equation.
Participants must agree to practice an acceptable method of contraception as outlined in the protocol.

Exclusion

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.
History of significant renal, hepatic, cardiovascular (including orthostatic hypotension), psychiatric, neoplastic, inflammatory, infectious, diabetes mellitus, or other disease which, in the opinion of the Investigator, represents a safety risk for taking part in the study.
Presence of any clinically significant results from laboratory tests, vital signs assessments, and electrocardiograms, as judged by the Investigator and/or designee.
Any degree of hepatic impairment based on liver function testing (abnormal ALT, AST, bilirubin, alkaline phosphatase, prothrombin time and international normalized ratio during screening).
Demonstrates a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
Reports a clinically significant illness during the 28 days prior to first dose (as determined by the Investigator and/or designee).
Subjects with known hypersensitivity to sildenafil or any component in the study medication, such as peppermint oil.
Reports a history of clinically significant allergies including food or drug allergies as judged by the Investigator.
History of drug abuse within the previous year, or a positive drug screen (amphetamines, barbiturates, benzodiazepines, cannabinoids, Cocaine, Opiates, Phencyclidine, 3,4-methylenedioxymethamphetamine (MDMA)) at screening and/or Day -1.
Regular alcohol consumption of \>15 units per week, with one unit being equivalent to 330mL of beer or 125 mL of wine or 25 mL to 40 mL of ≥ 40% spirits, or a positive alcohol breathalyzer test at screening and/or Day -1.
Reports use of CYP enzyme inhibitors within 14 days prior to Period 1 dosing.
Reports use of CYP enzyme inducers or St. John's Wort within 28 days prior to Period 1 dosing.
Use of prescription or non-prescription drugs, including individual vitamins, herbal and dietary supplements within seven days or five half-lives, whichever is longer, unless in the opinion of the Investigator and Sponsor's medical monitor the medication is not expected to interfere with the study procedures or compromise subject safety (occasional use of acetaminophen, naproxen, and ibuprofen are allowed).
Blood donation or significant blood loss within 3 months before screening. All volunteers will be advised not to donate blood for 30 days after completing the study.
Reports donating plasma (e.g., plasmapheresis) within 14 days prior to first dose. All volunteers will be advised not to donate plasma for 30 days after completing the study.
Demonstrates, in the opinion of study staff, inadequate veins or veins unsuitable for repeated venipuncture (e.g., veins difficult to locate, access, or puncture; veins with a tendency to rupture during or after puncture).
Reports difficulty fasting or consuming standardized meals.
Subjects who have difficulty swallowing.
Regular use of tobacco (\>4 cigarettes per day) or nicotine-containing products within four weeks before screening, or urinary cotinine level indicative of active smoking at screening and/or Day -1
Major surgery within three months or minor surgery within one month before screening as per the Principal Investigator (PI) judgment.
Institutionalized volunteers.
Reports use of any hormone replacement therapy within 6 months prior to first dose.
Use of any products containing Seville oranges, grapefruit and pomelo within seven days prior to first dose and for the duration of the study.
Ingestion of any caffeine/xanthine containing products (coffee, tea, soft drinks, chocolate, energy drinks, etc.), foods containing poppy seeds within 48 hours prior to first dose and for the duration of the study.
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.
Subject administered COVID-19 vaccine within three days prior to each check-in.
Subjects with retainers, braces, dentures, partial dentures, and/or tongue piercing.
Subjects using the following within 14 days of first dose:
Antihypertensive medications.
PDE5 inhibitors
Subjects with known hypertension or blood pressure and heart rate outside of the following ranges:
Systolic blood pressure: 90 - 140 mmHg
Diastolic blood pressure: 50 - 90 mmHg
Heart rate at screening: 50 - 100 beats per minute

What this trial measures

  • CmaxBaseline and at 24 different timepoints during the 24 hour post-dose

    The PK profile of ASP-001 and Viagra in healthy male subjects. Calculation of maximum plasma concentration (Cmax) over the specified timeframe.

  • AbsorptionBaseline and at several timepoints during the 24 hour post-dose

    To determine if the rate and extent of absorption are similar for 100 mg of ASP-001 administered as 8 pumps of the 25 mg/mL oral liquid suspension of sildenafil compared to 100 mg Viagra (sildenafil) administered in the form of a film-coated tablet.

  • AUCtBaseline and at 24 different timepoints during the 24 hour post-dose

    The PK profile of ASP-001 and Viagra in healthy male subjects. Calculation of the area under the plasma concentration versus time curve will be calculated using the linear trapezoidal rule from the zero time point to the last quantifiable concentration (AUCt).

  • AUCiBaseline and at 24 different timepoints during the 24 hour post-dose

    The PK of ASP-001 and Viagra in healthy male subjects. The area under the plasma concentration versus time curve from zero to infinity (AUCi) will be calculated by adding the last quantifiable concentration (Ct)/ elimination rate contant (Kel) to AUCt.

  • TmaxBaseline and at 24 different timepoints during the 24 hour post-dose

    The PK of ASP-001 and Viagra in healthy male subjects. Calculation of the time of the maximum measured plasma concentration (Tmax). If the maximum plasma concentration occurs at more than one time point, the first is chosen as Tmax.

  • KelBaseline and at 24 different timepoints during the 24 hour post-dose

    The PK of ASP-001 and Viagra in healthy male subjects. Calculation of the terminal elimination rate constant obtained from the slope of the line, fitted by linear least squares regression, through the terminal points of the log (base e) of the concentration versus time plot for these timepoints.

  • tHalfBaseline and at 24 different timepoints during the 24 hour post-dose

    PK of ASP-001 and Viagra in healthy male subjects. The half-life will be calculated by the equation tHalf = 0.693/ Kel. Apparent elimination half-life.