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

NCT06782659 | Not Yet Recruiting Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: ASP-001-005-BE
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Erectile Dysfunction

Keywords

Erectile dysfunction; Viagra; Sildenafil; bioequivalence

Outcome Measures

Primary Outcomes (7)

• Cmax

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

  Baseline and at 24 different timepoints during the 24 hour post-dose

• Absorption

  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.

  Baseline and at several timepoints during the 24 hour post-dose

• AUCt

  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).

  Baseline and at 24 different timepoints during the 24 hour post-dose

• AUCi

  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.

  Baseline and at 24 different timepoints during the 24 hour post-dose

• Tmax

  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.

  Baseline and at 24 different timepoints during the 24 hour post-dose

• Kel

  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.

  Baseline and at 24 different timepoints during the 24 hour post-dose

• tHalf

  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.

  Baseline and at 24 different timepoints during the 24 hour post-dose

Secondary Outcomes (2)

• Number of participants with oral irritation, dizziness, or headache.

  Baseline and different timepoints during the 24 hour post-dose

• Number of participants with adverse events

  Baseline and at several timepoints during the 24 hours post-dose

Study Arms (2)

Arm 1 - ASP-001 and Viagra

EXPERIMENTAL

Participants receive 100 mg of ASP-001 followed by a 6 day washout before receiving 100 mg of Viagra

Drug: ASP-001; Drug: Viagra; Device: ASP-001

Arm 2 - Viagra and ASP-001

EXPERIMENTAL

Participants receive 100 mg of Viagra followed by a 6 day washout before receiving 100 mg of ASP-001

Drug: ASP-001; Drug: Viagra; Device: ASP-001

Interventions

ASP-001 DRUG

Oral liquid suspension of sildenafil

Arm 1 - ASP-001 and Viagra; Arm 2 - Viagra and ASP-001

Viagra DRUG

Sildenafil film-coated tablet

Arm 1 - ASP-001 and Viagra; Arm 2 - Viagra and ASP-001

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Cisgender
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aspargo Labs, Inc: lead

Study Sites (2)

Evolution Research Group, Clinical Pharmacology of Miami (CPMI)

Miami, Florida, 33014, United States

Location

Evolution Research Group, Clinical Pharmacology of Miami (CPMI)

Miami, Florida, 33172, 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 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: January 8, 2025
• First Posted: January 20, 2025
• Study Start: January 1, 2025
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)