Effect of Moderate Alcohol on Absorption and Onset of Hezkue Sildenafil Suspension

ConditionErectile Dysfunction

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexMale

Age18-70

SponsorAspargo Labs, Inc

About this trial

This is a Phase 2, open-label, randomized crossover study assessing the effect of moderate alcohol intake on the absorption and onset of action of Hezkue® sildenafil oral suspension in adult subjects. Participants will receive Hezkue® under different alcohol intake conditions in randomized sequence. Pharmacokinetic sampling and onset assessments will be performed after each administration, and safety will be monitored throughout the study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male adults 21 to 65 years of age, inclusive

Documented history of erectile dysfunction for at least 6 months, as determined by the investigator

In a stable sexual relationship and willing to attempt sexual activity as required by study procedures, if applicable

Medically stable based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations, in the opinion of the investigator

Disqualifiers

Known hypersensitivity or contraindication to sildenafil, other PDE5 inhibitors, alcohol, or any component of the Hezkue® formulation

Use of nitrates, nitric oxide donors, guanylate cyclase stimulators (such as riociguat), or other prohibited medications within a protocol-defined period

Clinically significant cardiovascular disease, including coronary artery disease, heart failure, clinically important arrhythmias, recent stroke, or uncontrolled hypertension or hypotension

Resting blood pressure or heart rate outside protocol-defined acceptable ranges at screening or baseline, in the opinion of the investigator

Trial design

Design model

Crossover

Treatments tested in this trial

Hezkue Sildenafil Oral Suspension
Drug
Hezkue® sildenafil oral suspension will be administered as a single oral dose in each study period under different alcohol intake conditions (such as with and without moderate alcohol consumption), according to the randomized crossover design. Pharmacokinetic, absorption, onset of action, and safety parameters will be assessed after each administration.
Moderate Alcohol Intake
Other intervention
A standardized moderate amount of alcohol will be administered under controlled conditions prior to dosing with Hezkue® sildenafil oral suspension in designated study periods, according to the protocol-defined alcohol intake procedures.

Treatment groups

36 Participants

are divided into 2 treatment groups

Group A: Single-Arm CrossoverExperimental treatment 1 intervention

Group B: Hezkue® With Moderate Alcohol IntakeExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Time to Onset of Effect as Assessed by Participant-Reported Erectile Response

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 Sildenafi

Time frame

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aspargo Labs, Inc

Lead sponsor

Source ClinicalTrials.gov

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