Clinical trial NCT04934124: Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Intra-Cellular Therapies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-06-22
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential ascending doses. Parallel (active, placebo) within each cohort
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percentage of subjects with treatment-emergent adverse events
timeFrame: up to 30 days after last dose
measure: Change from baseline in systolic and diastolic blood pressure
timeFrame: Up to Day 12
measure: Change from baseline in SAO2
timeFrame: Up to Day 12
measure: Change from baseline in ECG QT interval
timeFrame: Up to Day 12
measure: Change from baseline in hemoglobin
timeFrame: Up to Day 12
measure: Change from baseline in white blood cell count
timeFrame: Up to Day 12
measure: Change from baseline in aspartate aminotransferase
timeFrame: Up to Day 12
measure: Change from baseline in alanine aminotransferase
timeFrame: Up to Day 12
Secondary outcomes:
measure: Pharmacokinetics: AUC0-t
timeFrame: predose and multiple timepoints up to 96 hours postdose
measure: Pharmacokinetics: AUC0-inf
timeFrame: predose and multiple timepoints up to 96 hours postdose
measure: Pharmacokinetics: Cmax
timeFrame: predose and multiple timepoints up to 96 hours postdose
measure: Pharmacokinetics: Tmax
timeFrame: predose and multiple timepoints up to 96 hours postdose
measure: Pharmacokinetics: T1/2
timeFrame: predose and multiple timepoints up to 96 hours postdose
measure: Pharmacokinetics: CL/F
timeFrame: predose and multiple timepoints up to 96 hours postdose
measure: Pharmacokinetics: Vz/F
timeFrame: predose and multiple timepoints up to 96 hours postdose
Other outcomes:
Locations:
city: Eatontown
country: United States
facility: Clinical Site
state: New Jersey
Study officials:
References: