NCT07302698Not yet recruitingPhase 1
Evaluation of the Pharmacokinetics and Onset Performance of Hezkue® Oral Sildenafil Suspension Following Alcohol Consumption in Healthy Adults
Aspargo Labs, Inc0 sites24 target enrollmentStarted: March 15, 2026Last updated:
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 24
- Primary Endpoint
- Maximum Observed Plasma Concentration (Cmax) of Sildenafil
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Single-Arm Crossover
Experimental
Intervention: Hezkue Oral Sildenafil Suspension (Drug)
Outcomes
Primary Outcomes
Maximum Observed Plasma Concentration (Cmax) of Sildenafil
Time Frame: From predose up to approximately 24 hours postdose in each study period
Time to Onset of Effect as Assessed by Participant-Reported Onset
Time Frame: From dosing up to approximately 4 hours postdose in each study period
Area Under the Plasma Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC₀-t) of Sildenafil
Time Frame: From predose up to approximately 24 hours postdose in each study period
Secondary Outcomes
No secondary outcomes reported
Investigators
Similar Trials
Recruiting
Phase 1
A Phase I study to evaluate the pharmacokinetics, safety and tolerability of multiple oral doses of obefazimod in participants with renal impairment and matched normal kidney function.2024-514561-20-00Abivax48
Recruiting
Phase 1
A Clinical Study of SHR-A1811(sc) Subcutaneous Injection in Patients With Solid TumorNCT07275242Suzhou Suncadia Biopharmaceuticals Co., Ltd.107
Recruiting
Phase 1
Phase I Study of CPD704 Inhalation Suspension in Healthy SubjectsNCT07301203Beijing Tide Pharmaceutical Co., Ltd90
Recruiting
Phase 1
Pharmacokinetics of Olverembatinib in Participants With Hepatic ImpairmentNCT07282093Ascentage Pharma Group Inc.48
Recruiting
Phase 1
A Phase I Study of SIM0609 in Adult Participants With Locally Advanced/Metastatic Solid TumorsNCT07265921Jiangsu Simcere Pharmaceutical Co., Ltd.232