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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: [14C]-ITI-1284

• Registration Number: NCT06786286
• Lead Sponsor: Intra-Cellular Therapies, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-01-15
• Study First Posted: 2025-01-22
• Study Start: 2025-01-28
• Primary Completion: 2025-03-26
• Study Completion: 2025-03-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[14C]-ITI-1284 20 mg	[14C]-ITI-1284	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Clinical Site 1; 🇬🇧 Nottingham, United Kingdom