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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04934124
• Other study ID #: ITI-333-001
• Secondary ID: 1UG3DA047699-01
• Status: Completed
• Phase: Phase 1
• Start date: December 23, 2020
• Est. completion date: August 23, 2021

Study information

• Verified date: March 2023
• Source: Intra-Cellular Therapies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 23, 2021
• Est. primary completion date: August 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• ITI-333
ITI-333 oral solution

Other:
• Placebo
Matching placebo

Locations

Country	Name	City	State
United States	Clinical Site	Eatontown	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Intra-Cellular Therapies, Inc.	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with treatment-emergent adverse events		up to 30 days after last dose
Primary	Change from baseline in systolic and diastolic blood pressure		Up to Day 12
Primary	Change from baseline in SAO2		Up to Day 12
Primary	Change from baseline in ECG QT interval		Up to Day 12
Primary	Change from baseline in hemoglobin		Up to Day 12
Primary	Change from baseline in white blood cell count		Up to Day 12
Primary	Change from baseline in aspartate aminotransferase		Up to Day 12
Primary	Change from baseline in alanine aminotransferase		Up to Day 12
Secondary	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
Secondary	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
Secondary	Pharmacokinetics: Cmax	Maximum plasma concentration of ITI-333 and metabolites	predose and multiple timepoints up to 96 hours postdose
Secondary	Pharmacokinetics: Tmax	Time of maximum concentration of ITI-333 and metabolites in plasma	predose and multiple timepoints up to 96 hours postdose
Secondary	Pharmacokinetics: T1/2	Terminal elimination half-life of ITI-333 and metabolites	predose and multiple timepoints up to 96 hours postdose
Secondary	Pharmacokinetics: CL/F	Apparent oral clearance of ITI-333	predose and multiple timepoints up to 96 hours postdose
Secondary	Pharmacokinetics: Vz/F	Apparent volume of distribution of ITI-333	predose and multiple timepoints up to 96 hours postdose