A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults

ConditionSchizophrenia
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-55
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.

About this trial

The purpose of the present trial is to obtain information on the absorption, distribution, metabolism, excretion and pharmacokinetics (PK) of 14C-SEP-380135 and its metabolites following a single oral dose.

Eligibility criteria

Qualifiers

Body mass index (BMI) between 18.0 and 32.0 kilograms per square meter (kg/m²).

Medical history

Physical examination

Neurological examination

Disqualifiers

Have taken an investigational drug within 30 days or 5 half-lives, if known, (whichever is longer) prior to screening.

Have had prior exposure to SEP-380135.

Are currently participating in another clinical trial.

Attempted suicide within 12 months prior to screening.

Trial design

Treatments tested in this trial

  • 14C-SEP-380135

Treatment groups

8 Participants
are divided into 1 treatment group