MedTrace Logo

A Mass Balance Study Following Subcutaneous Administration of [14C]-ITI-1284 to Healthy Male Subjects

NCT06786286 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-04-16

No results posted yet for this study

Summary

ITI-1284-012 is an open-label, single-dose study to assess the mass balance recovery of radioactivity, and to evaluate the pharmacokinetics, safety and tolerability of ITI-1284 after a single subcutaneous dose of \[14C\]-ITI-1284 in healthy male subjects.

Conditions

  • Healthy Volunteers

Interventions

DRUG

[14C]-ITI-1284

\[14C\]-ITI-1284 20 mg oral solution (not more than 22 μCi), subcutaneous administration

Sponsors & Collaborators

  • Intra-Cellular Therapies, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2025-01-28
Primary Completion
2025-03-26
Completion
2025-03-26

Countries

  • United Kingdom

Study Locations

More Related Trials

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 NCT06786286 on ClinicalTrials.gov