Clinical trial NCT06786286: A Mass Balance Study Following Subcutaneous Administration of [14C]-ITI-1284 to Healthy Male Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Intra-Cellular Therapies, Inc.
Sponsor class: INDUSTRY
First posted: 2025-01-22
Enrollment: 8
Sex: MALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Mass balance recovery of total radioactivity in urine and feces combined
timeFrame: Day 1 up to Day 29
measure: Pharmacokinetics: AUC0-t for total radioactivity
timeFrame: Day 1 up to Day 29
measure: Pharmacokinetics: AUC0-t for ITI-1284
timeFrame: Day 1 to Day 8
measure: Pharmacokinetics: Cmax for total radioactivity
timeFrame: Day 1 up to Day 29
measure: Pharmacokinetics: Cmax for ITI-1284
timeFrame: Day 1 to Day 8
measure: Pharmacokinetics: Tmax for total radioactivity
timeFrame: Day 1 up to Day 29
measure: Pharmacokinetics: Tmax for ITI-1284
timeFrame: Day 1 to Day 8
Secondary outcomes:
measure: Percentage of subjects with treatment-emergent adverse events
timeFrame: Up to 30 days after the dose of study drug
measure: Change from baseline in systolic and diastolic blood pressure
timeFrame: Day 14
measure: Change from baseline in ECG QT interval
timeFrame: Day 14
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Clinical Site 1
Study officials:
References: