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

NCT06786286 | Completed Phase 1

• 1 other identifier: ITI-1284-012
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (3)

• 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

Study Arms (1)

[14C]-ITI-1284 20 mg

EXPERIMENTAL

Drug: [14C]-ITI-1284

Interventions

[14C]-ITI-1284 DRUG

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

[14C]-ITI-1284 20 mg

Eligibility Criteria

• Age: 30 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intra-Cellular Therapies, Inc.: lead

Study Sites (1)

Clinical Site 1

Nottingham, NG116JS, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 22, 2025
• Study Start: January 28, 2025
• Primary Completion: March 26, 2025
• Study Completion: March 26, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)