Hezkue®, Hezkue Turbo®, and Commercial Sildenafil Products in Fed Healthy Male Subject

NCT07117383 | Not Yet Recruiting Phase 1 FDA Drug FDA Device

• 1 other identifier: ASP-012-SIL
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare how different sildenafil formulations are absorbed and tolerated in healthy adult males under fed conditions. The main questions it aims to answer are: Do Hezkue and Hezkue Turbo differ in absorption compared to other commercial sildenafil products? Are there any differences in safety or tolerability between the products? Researchers will compare multiple formulations to evaluate differences in drug absorption and side effects.

Conditions

Erectile Dysfunction

Keywords

erectile dysfunction; Viagra; sildenafil; tadalafil

Outcome Measures

Primary Outcomes (2)

• Tmax - Time to Maximum Observed Plasma Concentration of Sildenafil

  Measurement of the time (Tmax) to reach maximum observed plasma concentration of sildenafil following a single oral dose under fed conditions.

  Baseline and up to 4 hours post-dose at 23 specified timepoints

• Cmax - Maximum Observed Plasma Concentration of Sildenafil

  Measurement of the maximum observed plasma concentration (Cmax) of sildenafil following a single oral dose of study drug.

  Baseline and at 23 timepoints within 4 hours post-dose.

Secondary Outcomes (2)

• Number of Participants Reporting Oral Irritation, Dizziness, or Headache

  From pre-dose through 96 hours post-dose.

• Number of Participants With Adverse Events

  From pre-dose through 96 hours post-dose.

Study Arms (2)

Hezkue Formulations

EXPERIMENTAL

Participants in this arm receive a single dose of 100mg (miligrams) of either Hezkue® (ASP-001) or Hezkue Turbo® (ASP-001.1), both liquid formulations containing sildenafil citrate.

Device: ASP-001.1; Drug: ASP-001

Commercially Available Sildenafil Products

EXPERIMENTAL

Participants in this arm receive a single dose of one of several comparator products, including commercially available sildenafil tablets or sildenafil + tadalafil combination chewables.

Drug: Commercial Sildenafil and Sildenafil/Tadalafil Products

Interventions

Commercial Sildenafil and Sildenafil/Tadalafil Products DRUG

A selection of marketed sildenafil or sildenafil + tadalafil products used as comparators. Includes tablets and chewables such as Viagra®, Galotam, BlueChew, Aristo Sildaristo, Lemonaid Viagra, Ro Sparks, Hims Hard Mints, and Hello Cake ED Cake Meds.

Also known as: Viagra®, Galotam, BlueChew, Aristo Sildaristo, Lemonaid Viagra, Ro Sparks, Hims Hard Mints, Hello Cake ED Cake Meds

Commercially Available Sildenafil Products

ASP-001.1 DEVICE

Bottle/pump containing ASP-001.1 suspension

Also known as: Hezkue®, sildenafil citrate oral suspension, sildenafil

Hezkue Formulations

ASP-001 DRUG

Oral liquid suspension of sildenafil

Also known as: Hezkue Turbo®, sildenafil citrate oral suspension, sildenafil

Hezkue Formulations

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Participant must be a healthy male, aged 18 to 70 years (inclusive) at the time of dosing.
• Participant 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.
• Participant must have a creatinine clearance (CrCl) value greater than 80 mL/min, as calculated by the Cockcroft-Gault equation.
• Participant must agree to practice an acceptable method of contraception throughout the clinical trial, as outlined in the protocol.

You may not qualify if:

• Unwilling or unable to comply with study procedures.
• Use of any investigational drug (except Hezkue/Hezkue Turbo) within 30 days prior to dosing.
• History of significant renal, hepatic, cardiovascular (including orthostatic hypotension), psychiatric, neoplastic, infectious disease, or diabetes mellitus.
• Clinically significant abnormal lab results, vital signs, or ECGs.
• Any hepatic impairment or abnormal liver function tests.
• Positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
• Clinically significant illness within 28 days prior to dosing.
• Known hypersensitivity to sildenafil, tadalafil, vardenafil, or any component of the investigational product (e.g., peppermint oil).
• History of significant food or drug allergies.
• History of drug abuse within the past year or positive drug screen at screening.
• Regular alcohol consumption exceeding 15 units per week.
• Use of CYP450 enzyme inhibitors within 14 days prior to dosing.
• Use of CYP450 enzyme inducers or St. John's Wort within 28 days prior to dosing.
• Blood donation or significant blood loss within 3 months before screening.
• Plasma donation within 14 days prior to first dose.

Sponsors & Collaborators

• Aspargo Labs, Inc: lead

Study Sites (1)

Aspargo Labs

New York, New York, 10004, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Mario Guralnik, PhD

  Aspargo Labs, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: January 1, 2026
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)