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

NCT ID: NCT06786286

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-28
• Study Completion Date: 2025-03-26

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

[14C]-ITI-1284 20 mg

Group Type: EXPERIMENTAL

[14C]-ITI-1284

Intervention Type: DRUG

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

Interventions

[14C]-ITI-1284

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Intra-Cellular Therapies, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Site 1

Nottingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

ITI-1284-012

Identifier Type: -

Identifier Source: org_study_id