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
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.
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.
Crossover
ASP-001.1
DrugOral liquid suspension of sildenafil
ASP-001.1
DeviceBottle/pump containing ASP-001.1 suspension
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.
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.
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.
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.
Number of participants with oral irritation, dizziness, or headache
To determine the potential of ASP-001.1 to cause oral irritation, dizziness, or headache. Descriptive summaries (mean, standard deviation (SD), median, minimum, and maximum) of actual values and changes from baseline will be provided.
Number of participants with adverse events
The frequency and type of adverse events reported during the study.
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