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

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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