Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Placebo; Drug: ITI-333

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Eatontown, New Jersey, United States, 07724
      • Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: 0.03 mg ITI-333 or placebo	Other: Placebo; Matching placebo; Drug: ITI-333; ITI-333 oral solution
Experimental: Cohort 2: 0.09 mg ITI-333 or placebo	Other: Placebo; Matching placebo; Drug: ITI-333; ITI-333 oral solution
Experimental: Cohort 3: 0.25 mg ITI-333 or placebo	Other: Placebo; Matching placebo; Drug: ITI-333; ITI-333 oral solution
Experimental: Cohort 4: 0.75 mg ITI-333 or placebo	Other: Placebo; Matching placebo; Drug: ITI-333; ITI-333 oral solution
Experimental: Cohort 5: 2.25 mg ITI-333 or placebo	Other: Placebo; Matching placebo; Drug: ITI-333; ITI-333 oral solution
Experimental: Cohort 6: 6.75 mg ITI-333 or placebo	Other: Placebo; Matching placebo; Drug: ITI-333; ITI-333 oral solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Change from baseline in alanine aminotransferase	Up to Day 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics: AUC0-t	Area under the plasma concentration time curve from time zero to the last measurable of concentration of ITI-333 and metabolites	predose and multiple timepoints up to 96 hours postdose
Pharmacokinetics: AUC0-inf	Area under the plasma concentration (ITI-333 and metabolites) time curve from time zero to infinity	predose and multiple timepoints up to 96 hours postdose
Pharmacokinetics: Cmax	Maximum plasma concentration of ITI-333 and metabolites	predose and multiple timepoints up to 96 hours postdose
Pharmacokinetics: Tmax	Time of maximum concentration of ITI-333 and metabolites in plasma	predose and multiple timepoints up to 96 hours postdose
Pharmacokinetics: T1/2	Terminal elimination half-life of ITI-333 and metabolites	predose and multiple timepoints up to 96 hours postdose
Pharmacokinetics: CL/F	Apparent oral clearance of ITI-333	predose and multiple timepoints up to 96 hours postdose
Pharmacokinetics: Vz/F	Apparent volume of distribution of ITI-333	predose and multiple timepoints up to 96 hours postdose

Collaborators and Investigators

• Sponsor: Intra-Cellular Therapies, Inc.
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2020
• Primary Completion (Actual): August 23, 2021
• Study Completion (Actual): August 23, 2021

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (Actual): June 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 10, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ITI-333-001; 1UG3DA047699-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No