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

NCT04934124 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: ITI-333-0011UG3DA047699-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (7)

• Pharmacokinetics: AUC0-t

  predose and multiple timepoints up to 96 hours postdose

• Pharmacokinetics: AUC0-inf

  predose and multiple timepoints up to 96 hours postdose

• Pharmacokinetics: Cmax

  predose and multiple timepoints up to 96 hours postdose

• Pharmacokinetics: Tmax

  predose and multiple timepoints up to 96 hours postdose

• Pharmacokinetics: T1/2

  predose and multiple timepoints up to 96 hours postdose

Study Arms (6)

Cohort 1: 0.03 mg ITI-333 or placebo

EXPERIMENTAL

Drug: ITI-333; Other: Placebo

Cohort 2: 0.09 mg ITI-333 or placebo

EXPERIMENTAL

Drug: ITI-333; Other: Placebo

Cohort 3: 0.25 mg ITI-333 or placebo

EXPERIMENTAL

Drug: ITI-333; Other: Placebo

Cohort 4: 0.75 mg ITI-333 or placebo

EXPERIMENTAL

Drug: ITI-333; Other: Placebo

Cohort 5: 2.25 mg ITI-333 or placebo

EXPERIMENTAL

Drug: ITI-333; Other: Placebo

Cohort 6: 6.75 mg ITI-333 or placebo

EXPERIMENTAL

Drug: ITI-333; Other: Placebo

Interventions

ITI-333 DRUG

ITI-333 oral solution

Cohort 1: 0.03 mg ITI-333 or placebo; Cohort 2: 0.09 mg ITI-333 or placebo; Cohort 3: 0.25 mg ITI-333 or placebo; Cohort 4: 0.75 mg ITI-333 or placebo; Cohort 5: 2.25 mg ITI-333 or placebo; Cohort 6: 6.75 mg ITI-333 or placebo

Placebo OTHER

Matching placebo

Cohort 1: 0.03 mg ITI-333 or placebo; Cohort 2: 0.09 mg ITI-333 or placebo; Cohort 3: 0.25 mg ITI-333 or placebo; Cohort 4: 0.75 mg ITI-333 or placebo; Cohort 5: 2.25 mg ITI-333 or placebo; Cohort 6: 6.75 mg ITI-333 or placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Clinical Site

Eatontown, New Jersey, 07724, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential ascending doses. Parallel (active, placebo) within each cohort

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 22, 2021
• Study Start: December 23, 2020
• Primary Completion: August 23, 2021
• Study Completion: August 23, 2021
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)