NCT03446274

An Open Label, Single-Dose Study of 14C-NW-3509 in Healthy Male Subjects

An Open Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-NW-3509 in Healthy Male Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Newron Pharmaceuticals SPA · Industry
• Sex: Male
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, open-label, non-randomized, single dose of 14C-NW-3509 capsule study in 6 healthy male subjects.

Detailed description

This is a single-center, open-label, non-randomized, single dose study in a single cohort of 6 healthy male subjects, including up to 2 cytochrome P450 (CYP)2D6 poor metabolizer subjects. Each subject will receive a single oral administration of 14C-NW-3509 capsule in the fasted state.The screening period and study admission to completion is estimated to be up to 43 days. The following data will be analyzed urine and feces data for total radioactivity, plasma and whole blood data for total radioactivity and plasma concentration data for NW-3509.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Evenamide	This is an orally available small molecule that potently blocks voltage-gated sodium channels (VGSCs) in vitro and is indicated for the treatment of patients with schizophrenia, mania, and bipolar disorder.

Timeline

• Start date: 2018-04-02
• Primary completion: 2018-04-23
• Completion: 2018-06-01
• First posted: 2018-02-26
• Last updated: 2018-06-19

Locations

1 site across 1 country: United Kingdom