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

NCT07455084 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-03-06

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

14C-SEP-380135

Oral Capsule

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-20
Primary Completion
2026-04-10
Completion
2026-05-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07455084 on ClinicalTrials.gov