NCT06786286

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

A Phase 1, Open-label Study to Assess the Mass Balance, Metabolism, Excretion and Pharmacokinetics of a Single Subcutaneous Dose of [14C]-ITI-1284 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Intra-Cellular Therapies, Inc. · Industry
• Sex: Male
• Age: 30 Years – 55 Years
• Healthy volunteers: Accepted

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

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

Timeline

• Start date: 2025-01-28
• Primary completion: 2025-03-26
• Completion: 2025-03-26
• First posted: 2025-01-22
• Last updated: 2025-04-16

Locations

1 site across 1 country: United Kingdom