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

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

The study will be conducted as a single-center, randomized, double-blind, placebo-controlled, ascending dose study in up to 4 sequential cohorts of healthy subjects. Each cohort will enroll 8 subjects: 6 subjects will receive ITI-333 and 2 subjects will receive placebo once daily for 14 days.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33014-3616
      • Recruiting
      • Clinical Site 1

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 (SpO2) < 96% and respiratory rate < 12 breaths per min;
• History of psychiatric condition that in the Investigator's opinion may be detrimental to participation in the study;
• CRP, ESR, or fibrinogen that are above normal reference ranges at Screening or Day 1.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: 0.75 mg ITI-333 or placebo once daily for 14 days	Other: Placebo; Matching placebo; Drug: ITI-333; ITI-333 oral solution
Experimental: Cohort 2: 1.5 mg ITI-333 or placebo once daily for 14 days	Other: Placebo; Matching placebo; Drug: ITI-333; ITI-333 oral solution
Experimental: Cohort 3: 3 mg ITI-333 or placebo once daily for 14 days	Other: Placebo; Matching placebo; Drug: ITI-333; ITI-333 oral solution
Experimental: Cohort 4: 6 mg ITI-333 or placebo once daily for 14 days	Other: Placebo; Matching placebo; Drug: ITI-333; ITI-333 oral solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects with treatment-emergent adverse events		up to 30 days after last dose
Pharmacokinetics: AUC0-tau	Area under the plasma drug concentration-time curve (AUC) from time zero to the end of dosing interval	predose and multiple timepoints up to 24 hours postdose on Days 1 and 14
Pharmacokinetics: Cmax	Maximum plasma concentration of ITI-333 and its metabolites over a dosing interval	predose and multiple timepoints up to 24 and 72 hours postdose on Days 1 and 14, respectively
Pharmacokinetics: Tmax	Time of maximum plasma concentration of ITI-333 and its metabolites over a dosing interval	predose and multiple timepoints up to 24 and 72 hours postdose on Days 1 and 14, respectively
Change from baseline in systolic and diastolic blood pressure		Up to Day 24
Change from baseline in SpO2		Up to Day 24
Change from baseline in ECG QT interval		Up to Day 24
Change from baseline in aspartate aminotransferase		Up to Day 24
Change from baseline in alanine aminotransferase		Up to Day 24

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2023
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 7, 2023
• First Posted (Actual): February 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ITI-333-002; 1UG3DA047699-02 (U.S. NIH Grant/Contract: National Institute on Drug Abuse (NIDA))

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