Pharmacoscintigraphic Study to Evaluate Two Sildenafil Products

NCT03510338 | Completed Phase 1

• 1 other identifier: BC230
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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

  24 hours

Secondary Outcomes (6)

• Extent of dispersion

  1 hour

• Visualisation of kinetics

  1 hour

• Change in oral examination findings post-dose

  1 hour

• Blood pressure

  24 hours

• Heart Rate

  24 hours

Study Arms (4)

Sublingual sildenafil (fasted)

EXPERIMENTAL

Subjects receive a single dose of 100 mg sildenafil

Drug: Sublingual sildenafil

Oral sildenafil (fed)

ACTIVE COMPARATOR

Subjects receive a single dose of 50 mg sildenafil (Viagra)

Drug: Oral sildenafil

Sublingual sildenafil (fed)

EXPERIMENTAL

Subjects receive a single dose of 100 mg sildenafil

Drug: Sublingual sildenafil

Oral comparator (fasted)

ACTIVE COMPARATOR

Subjects receive a single dose of 50 mg sildenafil (Viagra)

Drug: Oral sildenafil

Interventions

Sublingual sildenafil DRUG

100 mg biphasic sildenafil tablet

Also known as: N4S001

Sublingual sildenafil (fasted); Sublingual sildenafil (fed)

Oral sildenafil DRUG

50 mg oral sildenafil (Viagra)

Also known as: Viagra

Oral comparator (fasted); Oral sildenafil (fed)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Healthy male volunteers aged 18-65 years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• N4 Pharma UK Ltd.: lead
• BDD Pharma Ltd: collaborator

Study Sites (1)

BDD Pharma Ltd

Glasgow, G4 0SF, United Kingdom

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Howard NE Stevens, FRPharmS

  BDD Pharma Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: April 27, 2018
• Study Start: May 8, 2018
• Primary Completion: June 13, 2018
• Study Completion: June 13, 2018
• Last Updated: July 10, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)