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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: [14C]-ITI-1284

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG116JS
    • Clinical Site 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy male subjects between 30 and 55 years of age (inclusive);
• BMI between18.0 and 32.0 kg/m2, inclusive, at screening, and a minimum body weight of 50 kg at screening;
• Willing to be confined to the clinical research unit for the duration of the inpatient period of the study.

Exclusion Criteria:

• Radiation exposure, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposure, exceeding 5 mSev in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker shall participate in the study;
• Subjects who have been enrolled in a 14C-labeled product study in the 10 months prior to dosing with study drug on Day 1;
• Any clinical condition or procedure that may affect the absorption, distribution, biotransformation, or excretion of ITI-1284. Subjects with a history of appendectomy and/or abdominal wall hernia repair are eligible for study participation provided surgery was performed ≥1 year ago;
• Acute diarrhea or constipation in the 7 days before Day 1. If screening occurs > 7 days before Day 1, this criterion will be determined on Day 1;
• Clinically significant abnormal findings in vital sign assessments, supine SBP > 140 mmHg or < 90 mmHg, or supine DBP >90 mmHg or < 50 mmHg or supine pulse rate > 100 bpm or < 45 bpm at Screening;
• History of psychiatric condition that in the Investigator's opinion may be detrimental to participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C]-ITI-1284 20 mg	Drug: [14C]-ITI-1284; [14C]-ITI-1284 20 mg oral solution (not more than 22 μCi), subcutaneous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mass balance recovery of total radioactivity in urine and feces combined	percentage of total radioactivity	Day 1 up to Day 29
Pharmacokinetics: AUC0-t for total radioactivity	Area under the plasma drug concentration-time curve (AUC) from time zero to the last measurable concentration	Day 1 up to Day 29
Pharmacokinetics: AUC0-t for ITI-1284	Area under the plasma drug concentration-time curve (AUC) from time zero to the last measurable concentration	Day 1 to Day 8
Pharmacokinetics: Cmax for total radioactivity	Maximum plasma concentration	Day 1 up to Day 29
Pharmacokinetics: Cmax for ITI-1284	Maximum plasma concentration	Day 1 to Day 8
Pharmacokinetics: Tmax for total radioactivity	Time of maximum plasma concentration	Day 1 up to Day 29
Pharmacokinetics: Tmax for ITI-1284	Time of maximum plasma concentration	Day 1 to Day 8

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of subjects with treatment-emergent adverse events	Up to 30 days after the dose of study drug
Change from baseline in systolic and diastolic blood pressure	Day 14
Change from baseline in ECG QT interval	Day 14

Collaborators and Investigators

• Sponsor: Intra-Cellular Therapies, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2025
• Primary Completion (Actual): March 26, 2025
• Study Completion (Actual): March 26, 2025

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): January 22, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 11, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: ITI-1284-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No