The Objective of This Phase 1 Study is to Evaluate the Food Effect of 100 mg Hezkue Turbo® (ASP-001.1, Sildenafil) Under Fed Versus 100 mg of Hezkue Turbo® (ASP-001.1, Sildenafil) Under Fasted Conditions in Healthy Adult Male Subjects

NCT06872866 | Recruiting Phase 1 FDA Drug FDA Device

• 1 other identifier: ASP-001.1-010-FE
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this phase 1 study is to evaluate the food effect of 100 mg Hezkue Turbo® (ASP-001.1, sildenafil) under fed versus 100 mg of Hezkue Turbo® (ASP-001.1, sildenafil) under fasted conditions in healthy adult male subjects

Conditions

Erectile Dysfunction

Keywords

erectile dysfunction; viagra; sildenafil

Outcome Measures

Primary Outcomes (5)

• Cmax

  The PK profile of ASP-001.1 in healthy male subjects under fasted vs fed conditions. Calculation of maximum plasma concentration (Cmax) over the specified timeframe.

  Baseline and at 26 different timepoints during the 24 hour post-dose

• AUCt

  The PK of ASP-001.1 in healthy male subjects under fasted and fed conditions. 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 26 different timepoints during the 24 hour post-dose

• Tmax

  The PK of ASP-001.1 in healthy male subjects under fasted and fed conditions. 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 26 different timepoints during the 24 hour post-dose

• Thalf

  PK of ASP-001.1 in healthy male subjects under fasted and fed conditions. The half-life will be calculated by the equation tHalf = 0.693/ Kel. Apparent elimination half-life.

  Baseline and at 26 different timepoints during the 24 hour post-dose

• Kel

  The PK of ASP-001.1 in healthy male subjects under fasted and fed conditions. 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 26 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 24h post-dose

Study Arms (2)

Arm 1 - Fasted vs Fed Conditions

EXPERIMENTAL

Participants receive 100mg of ASP-001.1 first under fasted conditions and under fed conditions after

Drug: ASP-001.1; Device: ASP-001.1

Arm 2- Fed vs Fasted Conditions

EXPERIMENTAL

Participants receive 100mg of ASP-001.1 first under fed conditions and under fasted conditions after

Drug: ASP-001.1; Device: ASP-001.1

Interventions

ASP-001.1 DRUG

Oral liquid suspension of sildenafil

Arm 1 - Fasted vs Fed Conditions; Arm 2- Fed vs Fasted Conditions

Eligibility Criteria

• Age: 20 Years - 70 Years
• Gender Eligibility Details: cisgender
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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 20 to 70 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 330 mL 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 (1)

Aspargo Labs

New York, New York, 10004, United States

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

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

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: March 7, 2025
• First Posted: March 12, 2025
• Study Start: April 15, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

US (1)