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
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
Treatments tested in this trial
- Hezkue Sildenafil Oral Suspension
- Moderate Alcohol Intake
Treatment groups
36 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov