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

Sponsor
Newron Pharmaceuticals SPA
Study ID
NCT03446274
Phase
PHASE1
Status
Unknown

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
30 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Evenamide — DRUG
    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.

Study Details

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

Key Dates

First listed
Feb 26, 2018
Start date
Apr 2, 2018
Status verified
Jun 2018
Primary completion
Apr 23, 2018
Completion
Jun 30, 2018

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Primary Outcome Measure

Metabolic profiling for NW-3509 will be determined in plasma, urine and fecal samples [ Time Frame: 15 days ]

Central Contacts

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