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

StatusNot Yet Recruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 7 months later Apr 10, 2026 → Dec 2, 2026
See other at-risk trials from Astex Pharmaceuticals

Record History

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  1. Primary completion pushed from Apr 10, 2026 to Dec 2, 2026 Show 5 more changesShow less
    • Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. to Otsuka Pharmaceutical Development & Commercialization, Inc.
    • Start date: Mar 20, 2026 to Nov 1, 2026
    • Study completion pushed from May 3, 2026 to Dec 2, 2026
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 4 of 14 entries
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT07455084
Lead Sponsor Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions
(from sponsor)		 Schizophrenia
Related terms Schizophrenia
Enrollment 8 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov