Erectile DysfunctionPhase 1NCT03510338
Pharmacoscintigraphic Study to Evaluate Two Sildenafil Products
A Phase 1 study testing Sublingual sildenafil and Oral sildenafil in people with Erectile Dysfunction, run by N4 Pharma UK Ltd. at 1 site in United Kingdom.
Trial summary
The study will assess a new biphasic release sildenafil formulation (N4S001), developed by N4 Pharma. The N4S001 tablet contains a total of 100 mg sildenafil. The N4S001 tablet is designed to provide a faster onset of release and a longer therapeutic window compared to currently marketed sildenafil products. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Sublingual sildenafil and Oral sildenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 May 2018to 13 Jun 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- Aged between 18 and 65 years inclusive
- BMI between 18 and 30 kg/m2 inclusive
- Body weight ≥50 kg
- Understands and is willing, able and likely to comply with all study procedures and restrictions
- Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent (signed and dated) obtained before any trial related activities
- Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination
Who cannot join
- Current or recurrent disease that, in the opinion of the physician responsible, could affect the study conduct or laboratory assessments (e.g. hepatic disorders, renal insufficiency, congestive heart failure).
- Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures.
- A history of current or relevant previous non self-limiting gastrointestinal disorders.
- Currently suffering from disease known to impact gastric emptying, e.g. migraine, Type 1 or Type 2 diabetes mellitus.
- Currently suffering from any oromucosal condition (e.g. salivary gland disorders, xerostomia, aphthous ulcers) or recent oral surgery that in the opinion of the physician responsible could interfere with the study objectives.
- Currently or previously suffering from non-arteritic anterior ischaemic optic neuropathy (NAION).
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- Known hereditary degenerative retinal disorders such as retinitis pigmentosa.
- Hypotension (blood pressure <90/50 mmHg).
- Recent history of stroke or myocardial infarction.
- Laboratory screening results that suggest an abnormal liver and/or renal function.
- Subject has a screening QTc value of greater than or equal to 450 msec or an ECG that is not suitable for QTc measurements (e.g. poorly defined termination of the T-wave). The ECG taken at screening must be considered not clinically significant by the Investigator/ study physician.
- As a result of a physical examination or screening investigations, the physician responsible considers the volunteer unfit for the study.
- Subject has taken prescribed medication within 14 days prior to the first assessment visit which, in the opinion of the physician responsible, will interfere with the study procedures or compromise safety. Subjects will be withdrawn from subsequent study days if they commence taking prescribed medication during the study period which, in the opinion of the physician responsible, will interfere with the study procedures or compromise safety.
- Subject has taken over-the-counter (OTC) medication within 48 hours prior to the first assessment visit. This includes the use of vitamins and natural or herbal remedies. Subjects who have taken OTC medication may still be entered into the study if, in the opinion of the physician responsible, the medication will not interfere with the study procedures or compromise safety.
- Concomitant use of other phosphodiesterase 5 (PDE5) inhibitors, or other pulmonary arterial hypertension (PAH) treatments containing sildenafil (REVATIO), or other treatments for erectile dysfunction.
- Concomitant use of antihypertensive medications (e.g. diuretics, angiotensin converting enzyme (ACE) inhibitors etc).
- Concomitant use of nitrate medications.
- Recent history (within the last year) of alcohol or other substance abuse.
- Subject has an average weekly alcohol intake of greater than 21 units.
- Subject has positive urine drugs of abuse test at screening.
- Subject has a positive breath alcohol test at screening.
- Subject has recently discontinued smoking (less than 3 months).
- Subject is currently a smoker or user of nicotine-containing products.
- Subject has a positive urine cotinine test at screening.
- Subject has a history of allergy to sildenafil, to any component of the dosage form, or any other allergy, which in the opinion of the physician responsible, contraindicates their participation.
- Has an allergy to any of the contents of the standardised meals.
- Subject is vegetarian.
- Subject is lactose intolerant.
- Participation in another clinical study (inclusive of final post-study examination) or receipt of an investigational drug within the 12 weeks before first screening visit.
- Previous participation in this study.
- Subject whose participation in this study will result in participation in more than four studies over a twelve month period.
- An employee of the sponsor, client or study site or members of their immediate family.
- Subjects for whom participation in this study will exceed the limits of total radiation exposure allowed in the previous twelve month period (5 mSv), or will exceed 10 mSv over the previous three year period.
- Subjects who are intending to father a child in the 3 months following the study or are unwilling to abstain from sexual intercourse with pregnant or lactating women.
- Subjects who are unwilling to use a condom/spermicide in addition to having their female partner use another form of contraception such as an intrauterine device (IUD), diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation if the woman could become pregnant from the time of the assessment visit until 3 months following the study.
- Subject has donated blood or experienced significant blood loss within 3 months of screening and for the duration of the study.
- Difficulty accessing forearm veins for cannulation or blood sampling.
- Subject has any non-removable metal objects such as metal plates, screws etc in their chest or abdominal area, which in the opinion of the investigator, could affect the study conduct.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pharmacoscintigraphic Clinical Study to Evaluate a Biphasic Release Sildenafil Formulation (With Immediate and Sustained Release Components) Compared to a Marketed Sildenafil Product in Fed and Fasted States
The study will assess a new biphasic release sildenafil formulation (N4S001), developed by N4 Pharma. The N4S001 tablet contains a total of 100 mg sildenafil.
The N4S001 tablet is designed to provide a faster onset of release and a longer therapeutic window compared to currently marketed sildenafil products.
Read more
This is a single centre, open-label, four-arm crossover study in up to 12 healthy male volunteers.
The following treatments will be dosed:
Assessment Visit 1: N4S001 tablet containing 100 mg sildenafil (fasted)
Assessment Visit 2: N4S001 tablet containing 100 mg sildenafil (fed)
Assessment Visit 3: Viagra film-coated tablet containing 50 mg sildenafil (fasted)
Assessment Visit 4: Viagra film-coated tablet containing 50 mg sildenafil (fed)
The immediate release layer of each N4S001 tablet will be radiolabelled to contain 4 MBq (megabecquerel) 99mTc at time of dose.
Read the detailed description
A pharmacoscintigraphic clinical study will be undertaken to quantify the scintigraphic kinetics and extent of dispersion of the immediate release portion of the N4S001 tablet in the oral cavity, and to measure sildenafil and its main metabolite, N-desmethyl sildenafil, in the blood plasma. The study will comprise an open-label, four-treatment crossover study in up to 12 healthy male volunteers. All subjects will receive four treatments throughout the study. The initial fast onset release portion of each N4S001 tablet will be radiolabelled to enable the dispersion characteristics of this part of the formulation to be investigated in-vivo. The immediate release portion of the N4S001 tablet will be radiolabelled to contain approximately 4 MBq technetium-99m (99mTc) at time of dose (TOD). Blood samples will be taken at pre-defined times to allow pharmacokinetic (PK) evaluation of drug absorption of the N4S001 tablet and of the reference product, Viagra 50 mg film coated tablets. Blood pressure will be recorded at set time intervals to assess the effects of the N4S001 tablet against the reference product. Subjects will also assess the taste acceptability of the N4S001 tablet using a 7-point categorical scale and oral examinations will be completed to assess any local oral effects of N4S001.
- Conditions
- Erectile Dysfunction
- Being tested
- Sublingual sildenafil, Oral sildenafil
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublingual sildenafilDrug
Also called N4S001
100 mg biphasic sildenafil tablet
Oral sildenafilDrug
Also called Viagra
50 mg oral sildenafil (Viagra)
| Study group | Role | What they receive |
|---|---|---|
| Sublingual sildenafil (fasted) | Experimental | Subjects receive a single dose of 100 mg sildenafil Receives: Drug: Sublingual sildenafil |
| Oral sildenafil (fed) | Active comparator | Subjects receive a single dose of 50 mg sildenafil (Viagra) Receives: Drug: Oral sildenafil |
| Sublingual sildenafil (fed) | Experimental | Subjects receive a single dose of 100 mg sildenafil Receives: Drug: Sublingual sildenafil |
| Oral comparator (fasted) | Active comparator | Subjects receive a single dose of 50 mg sildenafil (Viagra) Receives: Drug: Oral sildenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sildenafil plasma concentrations
Measure sildenafil and its main metabolite in plasma and compare pharmacokinetic profiles with that of a marketed sildenafil product in fed and fasted states
Measured: 24 hours
Secondary outcomes (6)
Extent of dispersion
Quantification of extent of dispersion of the immediate release portion of the radiolabelled N4S001 tablet in the oral cavity using gamma scintigraphy
Measured: 1 hour
Visualisation of kinetics
Quantification the kinetics in the oral cavity of the immediate release portion of the radiolabelled N4S001 tablet using gamma scintigraphy
Measured: 1 hour
Change in oral examination findings post-dose
Assess changes in the oral cavity following dosing of the N4S001 tablet
Measured: 1 hour
Blood pressure
Systolic \& diastolic measurements will be used to assess the effects of the N4S001 tablet compared with the marketed sildenafil product
Measured: 24 hours
Heart Rate
Measurements will be used to assess the effects of the N4S001 tablet compared with the marketed sildenafil product
Measured: 24 hours
Questionnaire
Assessment of taste acceptability using a 7-point categorical scale
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start8 May 2018
- Primary completion13 Jun 2018
- Study completion13 Jun 2018
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.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- N4 Pharma UK Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BDD Pharma Ltd
- Responsible party
- Sponsor
- Investigators
- Howard NE Stevens, FRPharmS, Principal investigator, BDD Pharma Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510338
- Sponsor's protocol ID
- BC230
- Status last verified
- Jul 2018
- First submitted
- 12 Apr 2018
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacoscintigraphic Clinical Study to Evaluate a Biphasic Release Sildenafil Formulation (With Immediate and Sustained Release Components) Compared to a Marketed Sildenafil Product in Fed and Fasted States
- ClinicalTrials.gov ID
- NCT03510338
- Acronym / sponsor ID
- BC230
- Conditions
- Erectile Dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- N4 Pharma UK Ltd.Industry (pharma, biotech, devices)
- Collaborators
- BDD Pharma Ltd
- Study start
- 8 May 2018 (actual)
- Primary completion
- 13 Jun 2018 (actual)
- Study completion
- 13 Jun 2018 (actual)
- First posted
- 27 Apr 2018 (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 study will assess a new biphasic release sildenafil formulation (N4S001), developed by N4 Pharma. The N4S001 tablet contains a total of 100 mg sildenafil.
The N4S001 tablet is designed to provide a faster onset of release and a longer therapeutic window compared to currently marketed sildenafil products.
This is a single centre, open-label, four-arm crossover study in up to 12 healthy male volunteers.
The following treatments will be dosed:
Assessment Visit 1: N4S001 tablet containing 100 mg sildenafil (fasted)
Assessment Visit 2: N4S001 tablet containing 100 mg sildenafil (fed)
Assessment Visit 3: Viagra film-coated tablet containing 50 mg sildenafil (fasted)
Assessment Visit 4: Viagra film-coated tablet containing 50 mg sildenafil (fed)
The immediate release layer of each N4S001 tablet will be radiolabelled to contain 4 MBq (megabecquerel) 99mTc at time of dose.
Detailed description
A pharmacoscintigraphic clinical study will be undertaken to quantify the scintigraphic kinetics and extent of dispersion of the immediate release portion of the N4S001 tablet in the oral cavity, and to measure sildenafil and its main metabolite, N-desmethyl sildenafil, in the blood plasma. The study will comprise an open-label, four-treatment crossover study in up to 12 healthy male volunteers. All subjects will receive four treatments throughout the study. The initial fast onset release portion of each N4S001 tablet will be radiolabelled to enable the dispersion characteristics of this part of the formulation to be investigated in-vivo. The immediate release portion of the N4S001 tablet will be radiolabelled to contain approximately 4 MBq technetium-99m (99mTc) at time of dose (TOD). Blood samples will be taken at pre-defined times to allow pharmacokinetic (PK) evaluation of drug absorption of the N4S001 tablet and of the reference product, Viagra 50 mg film coated tablets. Blood pressure will be recorded at set time intervals to assess the effects of the N4S001 tablet against the reference product. Subjects will also assess the taste acceptability of the N4S001 tablet using a 7-point categorical scale and oral examinations will be completed to assess any local oral effects of N4S001.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sublingual sildenafil (fasted) | Experimental | Drug: Sublingual sildenafilSubjects receive a single dose of 100 mg sildenafil |
| Oral sildenafil (fed) | Active comparator | Drug: Oral sildenafilSubjects receive a single dose of 50 mg sildenafil (Viagra) |
| Sublingual sildenafil (fed) | Experimental | Drug: Sublingual sildenafilSubjects receive a single dose of 100 mg sildenafil |
| Oral comparator (fasted) | Active comparator | Drug: Oral sildenafilSubjects receive a single dose of 50 mg sildenafil (Viagra) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male
- Aged between 18 and 65 years inclusive
- BMI between 18 and 30 kg/m2 inclusive
- Body weight ≥50 kg
- Understands and is willing, able and likely to comply with all study procedures and restrictions
Key exclusion criteria (38 listed)
- Current or recurrent disease that, in the opinion of the physician responsible, could affect the study conduct or laboratory assessments (e.g. hepatic disorders, renal insufficiency, congestive heart failure).
- Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures.
- A history of current or relevant previous non self-limiting gastrointestinal disorders.
- Currently suffering from disease known to impact gastric emptying, e.g. migraine, Type 1 or Type 2 diabetes mellitus.
- Currently suffering from any oromucosal condition (e.g. salivary gland disorders, xerostomia, aphthous ulcers) or recent oral surgery that in the opinion of the physician responsible could interfere with the study objectives.
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 |
|---|---|---|
| Sublingual sildenafilAlso: N4S001100 mg biphasic sildenafil tablet | Drug | Sublingual sildenafil (fasted), Sublingual sildenafil (fed) |
| Oral sildenafilAlso: Viagra50 mg oral sildenafil (Viagra) | Drug | Oral comparator (fasted), Oral sildenafil (fed) |
Primary outcome
Sildenafil plasma concentrations
Time frame: 24 hours
Measure sildenafil and its main metabolite in plasma and compare pharmacokinetic profiles with that of a marketed sildenafil product in fed and fasted states
6 secondary outcomes
Extent of dispersion
Time frame: 1 hour
Visualisation of kinetics
Time frame: 1 hour
Change in oral examination findings post-dose
Time frame: 1 hour
Blood pressure
Time frame: 24 hours
Heart Rate
Time frame: 24 hours
Questionnaire
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- 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. This study is not recruiting at the moment.
Howard NE Stevens, FRPharmS principal investigator
BDD Pharma Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sublingual sildenafil and Oral sildenafil in people with Erectile Dysfunction, run by N4 Pharma UK Ltd. at 1 site in United Kingdom.
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 7 inclusion and 38 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: finished, as of the sponsor's last update on 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sildenafil plasma concentrations (time frame: 24 hours). 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 10 Jul 2018.