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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: ITI-333; Other: Placebo

• Registration Number: NCT04934124
• Lead Sponsor: Intra-Cellular Therapies, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-23
• Study First Submitted: 2021-06-14
• Study First Submitted QC: 2021-06-14
• Study First Posted: 2021-06-22
• Primary Completion: 2021-08-23
• Study Completion: 2021-08-23
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-10
• Last Update Posted: 2023-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change from baseline in systolic and diastolic blood pressure	Up to Day 12
Change from baseline in hemoglobin	Up to Day 12
Change from baseline in aspartate aminotransferase	Up to Day 12
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 SAO2	Up to Day 12
Change from baseline in ECG QT interval	Up to Day 12
Change from baseline in white blood cell count	Up to Day 12

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Clinical Site; 🇺🇸 Eatontown, New Jersey, United States