Erectile DysfunctionPhase 1NCT06782659
Study to Compare the Effects of Viagra® Vs Hezkue® in Healthy Fasted Male Participants.
A Phase 1 study testing ASP-001 and Viagra in people with Erectile Dysfunction, run by Aspargo Labs, Inc at 2 sites in United States.
Trial summary
The objective of this phase 1, open-label, single-center, two-way crossover trial is to evaluate the pharmacokinetics (PK), safety, and tolerability of 100 mg ASP-001 oral liquid suspension versus 100 mg Viagra (sildenafil citrate) tablets in fasted, healthy male volunteers Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- ASP-001 and Viagra
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2025to Mar 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to 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 18 to 55 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.
Who cannot join
- 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.
Show all 36Show fewer
- 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 330mL 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 (e.g., plasmapheresis) 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.
- 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.
- 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.
- 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:
- Antihypertensive medications.
- PDE5 inhibitors
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Evolution Research Group, Clinical Pharmacology of Miami (CPMI)
Miami, Florida, 33014
Cheryl Duggan, 305-817-2900, cduggan@ergclinical.com
Evolution Research Group, Clinical Pharmacology of Miami (CPMI)
Miami, Florida, 33172
Cheryl Duggan, 305-817-2900, cduggan@ergclinical.com
About this study
Official title: A Phase 1 Pharmacokinetic/Bioequivalence Study of 100 Mg of HEZKUE® (ASP-001, Sildenafil) Versus 100 Mg of VIAGRA® (Sildenafil) Film-Coated Tablets Under Fasted Conditions in Healthy Adult Male Subjects
The objective of this phase 1, open-label, single-center, two-way crossover trial is to evaluate the pharmacokinetics (PK), safety, and tolerability of 100 mg ASP-001 oral liquid suspension versus 100 mg Viagra (sildenafil citrate) tablets in fasted, healthy male volunteers
Read the detailed description
This is a Phase 1, open-label, single-center, two-way crossover study to evaluate the pharmacokinetics (PK), bioequivalence (BE), safety, and tolerability of ASP-001 (oral liquid suspension of sildenafil) compared to Viagra (sildenafil film-coated tablet) under fasted conditions in 56 healthy adult male participants.
The study aims to demonstrate bioequivalence between the ASP-001 and Viagra formulations and to evaluate whether the absorption rate of ASP-001 is superior to that of Viagra. Additionally, the study assesses the tolerability of ASP-001, including potential for oral irritation, dizziness, or headache.
Participants are randomized to one of these two sequences:
- Sequence 1: ASP-001 in Period I, Viagra in Period II.
- Sequence 2: Viagra in Period I, ASP-001 in Period II
There is a washout period of 6 days between treatment periods.
Enrollment may be increased at any point in this trial to ensure a minimum of 56 evaluable participants.
- Conditions
- Erectile Dysfunction
- Being tested
- ASP-001, Viagra
- Keywords
- Erectile dysfunction, Viagra, Sildenafil, bioequivalence
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP-001Drug
Oral liquid suspension of sildenafil
ViagraDrug
Sildenafil film-coated tablet
ASP-001Device
Bottle/pump containing ASP-001 suspension
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - ASP-001 and Viagra | Experimental | Participants receive 100 mg of ASP-001 followed by a 6 day washout before receiving 100 mg of Viagra Receives: Drug: ASP-001; Drug: Viagra; Device: ASP-001 |
| Arm 2 - Viagra and ASP-001 | Experimental | Participants receive 100 mg of Viagra followed by a 6 day washout before receiving 100 mg of ASP-001 Receives: Drug: ASP-001; Drug: Viagra; Device: ASP-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
The PK profile of ASP-001 and Viagra in healthy male subjects. Calculation of maximum plasma concentration (Cmax) over the specified timeframe.
Measured: Baseline and at 24 different timepoints during the 24 hour post-dose
Absorption
To determine if the rate and extent of absorption are similar for 100 mg of ASP-001 administered as 8 pumps of the 25 mg/mL oral liquid suspension of sildenafil compared to 100 mg Viagra (sildenafil) administered in the form of a film-coated tablet.
Measured: Baseline and at several timepoints during the 24 hour post-dose
AUCt
The PK profile of ASP-001 and Viagra in healthy male subjects. Calculation of the area under the plasma concentration versus time curve will be calculated using the linear trapezoidal rule from the zero time point to the last quantifiable concentration (AUCt).
Measured: Baseline and at 24 different timepoints during the 24 hour post-dose
AUCi
The PK of ASP-001 and Viagra in healthy male subjects. 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.
Measured: Baseline and at 24 different timepoints during the 24 hour post-dose
Tmax
The PK of ASP-001 and Viagra in healthy male subjects. 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.
Measured: Baseline and at 24 different timepoints during the 24 hour post-dose
Kel
The PK of ASP-001 and Viagra in healthy male subjects. 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.
Measured: Baseline and at 24 different timepoints during the 24 hour post-dose
tHalf
PK of ASP-001 and Viagra in healthy male subjects. The half-life will be calculated by the equation tHalf = 0.693/ Kel. Apparent elimination half-life.
Measured: Baseline and at 24 different timepoints during the 24 hour post-dose
Secondary outcomes (2)
Number of participants with oral irritation, dizziness, or headache.
To determine the potential of ASP-001 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.
Measured: 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.
Measured: Baseline and at several timepoints during the 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by Aspargo Labs, IncThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aspargo Labs, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782659
- Sponsor's protocol ID
- ASP-001-005-BE
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Pharmacokinetic/Bioequivalence Study of 100 Mg of HEZKUE® (ASP-001, Sildenafil) Versus 100 Mg of VIAGRA® (Sildenafil) Film-Coated Tablets Under Fasted Conditions in Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT06782659
- Acronym / sponsor ID
- ASP-001-005-BE
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile dysfunction, Viagra, Sildenafil, bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Aspargo Labs, IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2025 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this phase 1, open-label, single-center, two-way crossover trial is to evaluate the pharmacokinetics (PK), safety, and tolerability of 100 mg ASP-001 oral liquid suspension versus 100 mg Viagra (sildenafil citrate) tablets in fasted, healthy male volunteers
Detailed description
This is a Phase 1, open-label, single-center, two-way crossover study to evaluate the pharmacokinetics (PK), bioequivalence (BE), safety, and tolerability of ASP-001 (oral liquid suspension of sildenafil) compared to Viagra (sildenafil film-coated tablet) under fasted conditions in 56 healthy adult male participants.
The study aims to demonstrate bioequivalence between the ASP-001 and Viagra formulations and to evaluate whether the absorption rate of ASP-001 is superior to that of Viagra. Additionally, the study assesses the tolerability of ASP-001, including potential for oral irritation, dizziness, or headache.
Participants are randomized to one of these two sequences:
- Sequence 1: ASP-001 in Period I, Viagra in Period II.
- Sequence 2: Viagra in Period I, ASP-001 in Period II
There is a washout period of 6 days between treatment periods.
Enrollment may be increased at any point in this trial to ensure a minimum of 56 evaluable participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - ASP-001 and Viagra | Experimental | Drug: ASP-001, Drug: Viagra, Device: ASP-001Participants receive 100 mg of ASP-001 followed by a 6 day washout before receiving 100 mg of Viagra |
| Arm 2 - Viagra and ASP-001 | Experimental | Drug: ASP-001, Drug: Viagra, Device: ASP-001Participants receive 100 mg of Viagra followed by a 6 day washout before receiving 100 mg of ASP-001 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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 18 to 55 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.
Key exclusion criteria (36 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASP-001Oral liquid suspension of sildenafil | Drug | Arm 1 - ASP-001 and Viagra, Arm 2 - Viagra and ASP-001 |
| ViagraSildenafil film-coated tablet | Drug | Arm 1 - ASP-001 and Viagra, Arm 2 - Viagra and ASP-001 |
| ASP-001Bottle/pump containing ASP-001 suspension | Device | Arm 1 - ASP-001 and Viagra, Arm 2 - Viagra and ASP-001 |
Primary outcome
Cmax
Time frame: Baseline and at 24 different timepoints during the 24 hour post-dose
The PK profile of ASP-001 and Viagra in healthy male subjects. Calculation of maximum plasma concentration (Cmax) over the specified timeframe.
Absorption
Time frame: Baseline and at several timepoints during the 24 hour post-dose
To determine if the rate and extent of absorption are similar for 100 mg of ASP-001 administered as 8 pumps of the 25 mg/mL oral liquid suspension of sildenafil compared to 100 mg Viagra (sildenafil) administered in the form of a film-coated tablet.
AUCt
Time frame: Baseline and at 24 different timepoints during the 24 hour post-dose
The PK profile of ASP-001 and Viagra in healthy male subjects. Calculation of the area under the plasma concentration versus time curve will be calculated using the linear trapezoidal rule from the zero time point to the last quantifiable concentration (AUCt).
AUCi
Time frame: Baseline and at 24 different timepoints during the 24 hour post-dose
The PK of ASP-001 and Viagra in healthy male subjects. 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
Time frame: Baseline and at 24 different timepoints during the 24 hour post-dose
The PK of ASP-001 and Viagra in healthy male subjects. 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.
Kel
Time frame: Baseline and at 24 different timepoints during the 24 hour post-dose
The PK of ASP-001 and Viagra in healthy male subjects. 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.
tHalf
Time frame: Baseline and at 24 different timepoints during the 24 hour post-dose
PK of ASP-001 and Viagra in healthy male subjects. The half-life will be calculated by the equation tHalf = 0.693/ Kel. Apparent elimination half-life.
2 secondary outcomes
Number of participants with oral irritation, dizziness, or headache.
Time frame: Baseline and different timepoints during the 24 hour post-dose
Number of participants with adverse events
Time frame: Baseline and at several timepoints during the 24 hours post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Evolution Research Group, Clinical Pharmacology of Miami (CPMI)
Miami, United States
Evolution Research Group, Clinical Pharmacology of Miami (CPMI)
Miami, United States
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASP-001 and Viagra in people with Erectile Dysfunction, run by Aspargo Labs, Inc at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Baseline and at 24 different timepoints during the 24 hour post-dose). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.