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

Part of paid clinical trials in Lincoln, Nebraska.

Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study ID
NCT07455084
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 20, 2026
Status verified
Mar 2026
Primary completion
Apr 10, 2026
Completion
May 3, 2026

Study Design

Enrollment
8 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 14C-SEP-380135
    Participants receive a single oral administration of 14C-SEP-380135 on Day 1.

Primary Outcome Measure

Total Radioactivity Amount Excreted in Urine (Ae,u) [ Time Frame: Up to Day 8 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Celerion, Inc.LincolnNebraska68502-

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