Healthy Volunteers
Conditions
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.
Interventions
DRUG[14C]-ITI-1284
\[14C\]-ITI-1284 20 mg oral solution (not more than 22 μCi), subcutaneous administration
Sponsors
Intra-Cellular Therapies, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics: Tmax for ITI-1284 | Day 1 to Day 8 | Time of maximum plasma 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 |
| Pharmacokinetics: Tmax for total radioactivity | Day 1 up to Day 29 | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in systolic and diastolic blood pressure | Day 14 |
| Change from baseline in ECG QT interval | Day 14 |
| Percentage of subjects with treatment-emergent adverse events | Up to 30 days after the dose of study drug |
Countries
United Kingdom
Outcome results
None listed