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Compares treatment options for Erectile Dysfunction
Official title 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
ClinicalTrials.gov ID: NCT06872866
What this study is testing
What is ASP-001.1?
ASP-001.1 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for erectile dysfunction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 70, men only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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...
- Participants must have a creatinine clearance (CrCl) value greater than 80 mL/min, as calculated by the Cockcroft-Gault equation.
You likely can't join if
- 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...
- Presence of any clinically significant results from laboratory tests, vital signs assessments, and electrocardiograms, as judged by the Investigator...
- Any degree of hepatic impairment based on liver function testing (abnormal ALT, AST, bilirubin, alkaline phosphatase, prothrombin time and...
- Demonstrates a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
See the full eligibility criteria
Who can join
- 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...
- 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.
What rules you out
- 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...
- 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).
- people 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...
- 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...
- 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...
- 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...
- Reports difficulty fasting or consuming standardized meals.
- Reports intolerance to fatty foods or cannot consume a high-calorie and high-fat breakfast.
- people 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.
- people with retainers, braces, dentures, partial dentures, and/or tongue piercing.
- people 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) people 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...
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 20 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.