Erectile Dysfunction
Conditions
Keywords
erectile dysfunction, viagra, sildenafil
Brief summary
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
Detailed description
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.
Interventions
DRUGASP-001.1
Oral liquid suspension of sildenafil
Sponsors
Aspargo Labs, Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 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. * Participants must have a creatinine clearance (CrCl) value greater than 80 mL/min, as calculated by the Cockcroft-Gault equation. * Participants must agree to practice an acceptable method of contraception as outlined in the protocol.
Exclusion criteria
* 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. * Any degree of hepatic impairment based on liver function testing (abnormal ALT, AST, bilirubin, alkaline phosphatase, prothrombin time and international normalized ratio during screening). * Demonstrates a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody. * Reports a clinically significant illness during the 28 days prior to first dose (as determined by the Investigator and/or designee). * Subjects with known hypersensitivity to sildenafil or any component in the study medication, such as peppermint oil. * Reports a history of clinically significant allergies including food or drug allergies as judged by the Investigator. * History of drug abuse within the previous year, or a positive drug screen (amphetamines, barbiturates, benzodiazepines, cannabinoids, Cocaine, Opiates, Phencyclidine, 3,4-methylenedioxymethamphetamine (MDMA)) at screening and/or Day -1. * Regular alcohol consumption of \>15 units per week, with one unit being equivalent to 330 mL of beer or 125 mL of wine or 25 mL to 40 mL of ≥ 40% spirits, or a positive alcohol breathalyzer test at screening and/or Day -1. * Reports use of CYP enzyme inhibitors within 14 days prior to Period 1 dosing. * Reports use of CYP enzyme inducers or St. John's Wort within 28 days prior to Period 1 dosing. * Use of prescription or non-prescription drugs, including individual vitamins, herbal and dietary supplements within seven days or five half-lives, whichever is longer, unless in the opinion of the Investigator and Sponsor's medical monitor the medication is not expected to interfere with the study procedures or compromise subject safety (occasional use of acetaminophen, naproxen, and ibuprofen are allowed). * Blood donation or significant blood loss within 3 months before screening. All volunteers will be advised not to donate blood for 30 days after completing the study. * Reports donating plasma within 14 days prior to first dose. All volunteers will be advised not to donate plasma for 30 days after completing the study. * Demonstrates, in the opinion of study staff, inadequate veins or veins unsuitable for repeated venipuncture (e.g., veins difficult to locate, access, or puncture; veins with a tendency to rupture during or after puncture). * Reports difficulty fasting or consuming standardized meals. * Reports intolerance to fatty foods or cannot consume a high-calorie and high-fat breakfast. * Subjects who have difficulty swallowing. * Regular use of tobacco (\>4 cigarettes per day) or nicotine-containing products within four weeks before screening, or urinary cotinine level indicative of active smoking at screening and/or Day -1 * Major surgery within three months or minor surgery within one month before screening as per the Principal Investigator (PI) judgment. * If, in the opinion of the PI, the subject is not suitable for the study. * Subject administered COVID-19 vaccine within three days prior to each check-in. * Subjects with retainers, braces, dentures, partial dentures, and/or tongue piercing. * Subjects using the following within 14 days of first dose: * Nitric oxide donors, such as organic nitrates or organic nitrites in any form * Antihypertensive medications * PDE5 inhibitors (e.g., sildenafil, tadalafil, vardenafil) Subjects with known hypertension or blood pressure and heart rate outside of the following ranges: * Systolic blood pressure: 90 - 140 mmHg * Diastolic blood pressure: 50 - 90 mmHg * Heart rate at screening: 50 - 100 beats per minute * Institutionalized volunteers. * Reports use of any hormone replacement therapy within 6 months prior to first dose. * Use of any products containing Seville oranges, grapefruit and pomelo within seven days prior to first dose and for the duration of the study. * Ingestion of any caffeine/xanthine containing products (coffee, tea, soft drinks, chocolate, energy drinks, etc.), foods containing poppy seeds within 48 hours prior to first dose and for the duration of the study. * Ingestion of any beverages containing more than 5% fruit juice (fruit drinks, fruit punches, fruit cocktails, fruit-ades, or other products containing 5% or less of fruit juice will be allowed) within 48 hours prior to first dose and for the duration of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCt | Baseline and at 26 different timepoints during the 24 hour post-dose | 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. |
| Thalf | Baseline and at 26 different timepoints during the 24 hour post-dose | 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. |
| Kel | Baseline and at 26 different timepoints during the 24 hour post-dose | 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. |
| Cmax | Baseline and at 26 different timepoints during the 24 hour post-dose | 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. |
| Tmax | Baseline and at 26 different timepoints during the 24 hour post-dose | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with oral irritation, dizziness, or headache | Baseline and different timepoints during the 24 hour post-dose | 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 | Baseline and at several timepoints during the 24h post-dose | The frequency and type of adverse events reported during the study. |
Countries
United States
Outcome results
None listed