Healthy Volunteers
Conditions
Brief summary
The study will be conducted as a single-center, randomized, double-blind, placebo-controlled, ascending dose study in up to 8 sequential cohorts of healthy subjects. Each cohort will enroll 8 subjects: 6 subjects will receive ITI-333 and 2 subjects will receive placebo as a single oral dose after a fast of at least 10 hours.
Interventions
DRUGITI-333
ITI-333 oral solution
OTHERPlacebo
Matching placebo
Sponsors
National Institute on Drug Abuse (NIDA)
Intra-Cellular Therapies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Sequential ascending doses. Parallel (active, placebo) within each cohort
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Healthy male and female subjects between 18 and 45 years old (inclusive); * BMI inclusive of 18-32 kg/m2 at screening and a minimum weight of 50 kg; * Willingness to remain in the clinic for the inpatient portion of the study and return for follow-up visit(s) as required by protocol and as deemed necessary by the Investigator; Key
Exclusion criteria
* Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the subject at risk or interfere with study outcome variables; this includes, but is not limited to, history of or current cardiac, hepatic, renal, neurologic, GI, pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy; * Clinically significant abnormal findings in vital sign assessments, including blood oxygen saturation (SAO2) \< 96% and \< 12 breaths per min; History of psychiatric condition that in the Investigator's opinion may be detrimental to participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in alanine aminotransferase | Up to Day 12 |
| Percentage of subjects with treatment-emergent adverse events | up to 30 days after last dose |
| Change from baseline in systolic and diastolic blood pressure | Up to Day 12 |
| Change from baseline in SAO2 | Up to Day 12 |
| Change from baseline in ECG QT interval | Up to Day 12 |
| Change from baseline in hemoglobin | Up to Day 12 |
| Change from baseline in white blood cell count | Up to Day 12 |
| Change from baseline in aspartate aminotransferase | Up to Day 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics: AUC0-inf | predose and multiple timepoints up to 96 hours postdose | Area under the plasma concentration (ITI-333 and metabolites) time curve from time zero to infinity |
| Pharmacokinetics: Cmax | predose and multiple timepoints up to 96 hours postdose | Maximum plasma concentration of ITI-333 and metabolites |
| Pharmacokinetics: Tmax | predose and multiple timepoints up to 96 hours postdose | Time of maximum concentration of ITI-333 and metabolites in plasma |
| Pharmacokinetics: T1/2 | predose and multiple timepoints up to 96 hours postdose | Terminal elimination half-life of ITI-333 and metabolites |
| Pharmacokinetics: CL/F | predose and multiple timepoints up to 96 hours postdose | Apparent oral clearance of ITI-333 |
| Pharmacokinetics: Vz/F | predose and multiple timepoints up to 96 hours postdose | Apparent volume of distribution of ITI-333 |
| Pharmacokinetics: AUC0-t | predose and multiple timepoints up to 96 hours postdose | Area under the plasma concentration time curve from time zero to the last measurable of concentration of ITI-333 and metabolites |
Countries
United States
Outcome results
None listed