NCT03510338

Pharmacoscintigraphic Study to Evaluate Two Sildenafil Products

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: N4 Pharma UK Ltd. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DRUG	Sublingual sildenafil	100 mg biphasic sildenafil tablet
DRUG	Oral sildenafil	50 mg oral sildenafil (Viagra)

Timeline

• Start date: 2018-05-08
• Primary completion: 2018-06-13
• Completion: 2018-06-13
• First posted: 2018-04-27
• Last updated: 2018-07-10

Locations

1 site across 1 country: United Kingdom