PK and Onset of Hezkue Oral Sildenafil Suspension After Alcohol Consumption

NCT07302698 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: ASP-021-Sil
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an open-label, randomized study evaluating the pharmacokinetics and onset performance of Hezkue® oral sildenafil suspension administered following moderate alcohol consumption in healthy adult subjects. Participants will receive Hezkue® under controlled alcohol-exposure conditions. Pharmacokinetic sampling, onset assessments, and safety evaluations will be conducted throughout the study.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Area Under the Plasma Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC₀-t) of Sildenafil

  From predose up to approximately 24 hours postdose in each study period

• Maximum Observed Plasma Concentration (Cmax) of Sildenafil

  From predose up to approximately 24 hours postdose in each study period

• Time to Onset of Effect as Assessed by Participant-Reported Onset

  From dosing up to approximately 4 hours postdose in each study period

Study Arms (1)

Single-Arm Crossover

EXPERIMENTAL

Drug: Hezkue Oral Sildenafil Suspension

Interventions

Hezkue Oral Sildenafil Suspension DRUG

Hezkue® oral sildenafil suspension will be administered as a single oral dose following controlled moderate alcohol consumption under fasting or standardized conditions, according to the study schedule, to evaluate pharmacokinetics, onset performance, and safety.

Single-Arm Crossover

Eligibility Criteria

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

You may qualify if:

• Male or female adults 21 to 55 years of age, inclusive.
• Body mass index (BMI) between 18.0 and 30.0 kg/m², inclusive.
• Medically healthy based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations, in the opinion of the investigator.
• Able to safely consume moderate amounts of alcohol as judged by the investigator (for example, no history of alcohol intolerance, alcohol use disorder, or alcohol-related medical complications).
• Blood pressure and heart rate within normal or non-clinically significant ranges at screening and baseline, in the opinion of the investigator.
• Non-smoker or light smoker (10 cigarettes per day or fewer, or equivalent) willing to abstain during study confinement periods.
• Able to understand and provide written informed consent before any study-specific procedures are performed.
• Willing and able to comply with all study requirements, including alcohol restrictions, fasting, dosing schedules, and pharmacokinetic and onset assessments.
• Females of childbearing potential must use acceptable contraception as determined by the investigator.

You may not qualify if:

• History or presence of any clinically significant cardiovascular disease, including but not limited to coronary artery disease, heart failure, clinically important arrhythmias, or uncontrolled hypertension or hypotension.
• Resting systolic blood pressure or diastolic blood pressure, or heart rate, outside protocol-defined acceptable ranges at screening or baseline, in the opinion of the investigator.
• Known hypersensitivity or contraindication to sildenafil, other phosphodiesterase type 5 (PDE5) inhibitors, alcohol, or any component of the study formulations.
• Current or recent use of nitrates, nitric oxide donors, or guanylate cyclase stimulators (for example, riociguat).
• History of significant hepatic, renal, gastrointestinal, neurologic, psychiatric, endocrine, hematologic, or respiratory disease that, in the investigator's opinion, could interfere with study participation or data interpretation.
• History of syncope, significant orthostatic hypotension, or other conditions that may be worsened by sildenafil or alcohol.
• History of alcohol use disorder, binge drinking patterns, or other substance use disorder, as determined by the investigator.
• Positive urine drug screen or positive alcohol test at screening (outside scheduled alcohol administration for the study) or at admission.
• Use of prescription or over-the-counter medications, herbal products, or dietary supplements within 14 days before the first study dose, unless considered acceptable by the investigator.
• Positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV.
• Participation in another clinical study or receipt of an investigational drug or device within 30 days or 5 half-lives (whichever is longer) before the first study dose.
• Donation of 450 mL or more of blood, or significant blood loss, within 8 weeks before the first study dose.
• Pregnant or breastfeeding females.
• Women of childbearing potential not using acceptable contraception.
• Any condition or circumstance that, in the opinion of the investigator, would make the participant unsuitable for the study or could interfere with compliance or study assessments.

Sponsors & Collaborators

• Aspargo Labs, Inc: lead

Central Study Contacts

Avi Guralnik

CONTACT

17189381157; avi.berg@synergy-cro.com

Study Design

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

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: March 15, 2026
• Primary Completion: May 15, 2026
• Study Completion: May 28, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share