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
This is a Phase 1, open-label, single-center, two-period, two-treatment crossover study designed to evaluate the pharmacokinetics (PK), food effect, safety, and tolerability of ASP-001.1 (oral liquid suspension of sildenafil) under fed versus fasted conditions in healthy adult male participants. The crossover design ensures that each participant receives ASP-001.1 under both fed and fasted conditions, allowing for direct within-subject comparison of the pharmacokinetic parameters. The study aims to determine the effect of food on the absorption and bioavailability of ASP-001.1 and to assess its safety and tolerability, including the potential for oral irritation, dizziness, or headache. Subjects will be randomly assigned to one of two sequences for the crossover study: * Sequence 1: ASP-001.1 under fasted conditions in Treatment Period 1, followed by ASP-001.1 under fed conditions in Treatment Period 2. * Sequence 2: ASP-001.1 under fed conditions in Treatment Period 1, followed by ASP-001.1 under fasted conditions in Treatment Period 2. Randomization will occur after screening and prior to Treatment Period 1 dosing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Aspargo Labs
New York, New York, United States
RECRUITINGCmax
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.
Time frame: Baseline and at 26 different timepoints during the 24 hour post-dose
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.
Time frame: Baseline and at 26 different timepoints during the 24 hour post-dose
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.
Time frame: Baseline and at 26 different timepoints during the 24 hour post-dose
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.
Time frame: Baseline and at 26 different timepoints during the 24 hour post-dose
Kel
The PK of ASP-001.1 in healthy male subjects under fasted and fed conditions. Calculation of the terminal elimination rate constant obtained from the slope of the line, fitted by linear least squares regression, through the terminal points of the log (base e) of the concentration versus time plot for these timepoints.
Time frame: Baseline and at 26 different timepoints during the 24 hour post-dose
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.
Time frame: Baseline and different timepoints during the 24 hour post-dose
Number of participants with adverse events
The frequency and type of adverse events reported during the study.
Time frame: Baseline and at several timepoints during the 24h post-dose
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